Latest news with #REMS
Yahoo
30-07-2025
- Business
- Yahoo
Strong sales acceleration of QUVIVIQ drives Idorsia toward profitability
Ad hoc announcement pursuant to Art. 53 LR QUVIVIQ™ (daridorexant): Strong performance and sales acceleration with total net sales of CHF 58 million in H1 2025 and increase of 145% compared to the same period in 2024, largely driven by sales in Europe. NDA approval with Simcere in China. Aprocitentan (TRYVIO/JERAYGO) commercial opportunity significantly improved with REMS removal and very positive real-world experience – engaging in partnership discussions. Net revenue H1 2025 of CHF 131 million – boosted by the CHF 32 million exclusivity fee and CHF 40 million milestone from Simcere recognized in H1 2025. US GAAP operating income H1 2025 of CHF 64 million and non-GAAP operating loss of CHF 15 m. Cash runway extended to the end of 2026 – on track to reach commercial profitability goal in 2026 and overall profitability starting from the end of 2027. Allschwil, Switzerland – July 30, 2025Idorsia Ltd (SIX: IDIA) today published its Financial Report for the first half of 2025. The results confirm that the commercial acceleration of QUVIVIQ coupled with the financial discipline implemented over the past 12 months have successfully delivered an operational turn-around. The company is on track to reach its target of overall profitability starting from the end of 2027. Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented: 'The commercial acceleration of QUVIVIQ, combined with our financial discipline, has put Idorsia on track to reach overall profitability starting from the end of 2027. We are advancing the assets in our pipeline that we believe will bring the greatest value to the company and patients. And by using 'lead where we can and partner where we should' as our guiding light, we intend to expand our strategic partnerships, starting with TRYVIO.' Srishti continued:'The removal of the REMS in the US, excellent feedback from early prescribers, and our market preparation work, have significantly improved the commercial opportunity and is making a great basis to engage in the partnership process. Hypertension experts at major centers of excellence confirm positive patient experiences and efficacy and safety consistent with our pivotal clinical trial. This includes the unique ability of TRYVIO to treat hypertensive patients with chronic kidney disease, a condition that is very common in millions of patients with difficult to control hypertension, and who are often underserved with the current guideline directed therapies.' Arno Groenewoud, Chief Financial Officer, commented: 'The excellent performance from QUVIVIQ, particularly in Europe, puts us on-track to reach our improved financial guidance provided in May 2025 and overall profitability starting from the end of 2027. With the newly secured CHF 150 million facility and an updated collaboration with Simcere, bringing an additional CHF 40 million in milestone payments, we have significantly strengthened our financial position and extended our cash runway through the end of 2026. We are currently carefully looking at all options to fund Idorsia to overall profitability starting from the end of 2027.' Commercial operationsIn the first half of 2025, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, Sweden, and Finland generated total product sales of CHF 56 million, over 140% increase compared to the same period in 2024. Europe and CanadaQUVIVIQ (daridorexant) net sales in the first half of 2025 reached CHF 44 million in the Europe and Canada (EUCAN) region, an almost 4 times increase from CHF 9 million in the first half of 2024. QUVIVIQ is the only long-term pharmacological treatment for insomnia in Europe and is on-track to become the standard of care. This is reflected by the performance and the extremely positive feedback from both healthcare professionals and patients. The keys to success are to secure public reimbursement, focused promotional efforts to specialist prescribers, and expansion to primary care through co-promotion partnerships and omnichannel initiatives. For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics. For more information about QUVIVIQ in Switzerland, see the Patient Information and Information for Healthcare Professionals. For more information on the marketing authorization of QUVIVIQ in Canada, see the Product Monograph. United StatesQUVIVIQ® (daridorexant) net sales in the first half of 2025 amounted to CHF 11.9 million in the US, compared to CHF 14.2 million in the first half of 2024, with a meaningful improvement in gross margin, driven by greater proportion of payer-paid prescriptions. At the beginning of 2025, the company implemented a streamlined, focused, and more cost-efficient commercialization approach for QUVIVIQ to maintain sales until the potential descheduling of the dual orexin receptor antagonist (DORA) class can be achieved. For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. In March 2025, the US FDA fully released TRYVIO from its REMS (Risk Evaluation and Mitigation Strategy) requirement to minimize the burden on the healthcare delivery system of complying with the REMS. As a result, a rapid transition from specialty pharmacy to a wide retail pharmacy distribution model is underway. Funding for a field sales force and promotional activities continues to be dependent on a partnership deal. For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Research & DevelopmentOur drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas, including CNS, cardiovascular, and immunological disorders, as well as orphan diseases. The company has completed a portfolio prioritization to advance four investigational clinical assets with the potential to transform treatment paradigms. Lucerastat: Idorsia has conducted a kidney biopsy sub-study belonging to the ongoing open-label extension (OLE) of the Phase 3 study. This sub-study enrolled male participants with classic Fabry disease who had been treated for more than 3 years with lucerastat monotherapy. The main objective of the sub-study was to evaluate the number of globotriaosylceramide (Gb3) inclusions in certain type of kidney cells using established methods of quantification. In parallel, a new interim analysis of the ongoing OLE of the Phase 3 study where ongoing participants had received lucerastat for at least 42 months was performed. The analysis corroborated the long-term effect on plasma Gb3 levels and a potential positive long-term effect on kidney function. It also confirmed the safety and tolerability profile observed during the 6-month randomized treatment period. The results of both the interim analysis and kidney biopsy sub-study are supportive of further investigation for patients with Fabry disease. The company is in ongoing discussions with the US FDA to agree on the optimal regulatory pathway to approval. Daridorexant: Idorsia is conducting a Phase 2 dose-finding study to assess the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric patients aged 10 to <18 years with insomnia disorder (NCT05423717). The primary objective of the study is to characterize the dose-response relationship of daridorexant on objective total sleep time (TST), using polysomnography. Patients will be randomized in a 1:1:1:1 ratio to 10 mg, 25 mg, or 50 mg daridorexant, or placebo and treated for 2 weeks. The study is expected to complete enrollment by the end of 2025 with readout expected around mid-2026. The study is part of a US FDA-approved Pediatric Study Plan and an EU PDCO-approved Paediatric Investigation Plan. Idorsia will also advance three first-in-class chemokine receptor antagonists into studies which will each be proof-of-concept in the specific indication under investigation as well as proof-of-mechanism for a range of disorders where the pathways can be applied. Key development assets CompoundMechanism of actionTarget indication Status LucerastatGlucosylceramide synthase inhibitorFabry disease New data and evaluation of long-term treatment with lucerastat supportive further investigation – regulatory pathway is under discussion with the FDA DaridorexantDual orexin receptor antagonistPediatric insomnia Phase 2 in pediatric insomnia ongoing with recruitment expected to conclude by end of 2025 with readout expected around mid-2026. IDOR-1117-2520CCR6 receptor antagonistPsoriasis Proof-of-concept study in preparation for patients with psoriasis. Unique potential as a first-in-class, oral, targeted systemic therapy for effective treatment of Th17-driven immuno-dermatology and autoimmune disorders. ACT-1004-1239ACKR3 (CXCR7) receptor antagonistProgressive multiple sclerosis Proof-of-concept study in preparation for patients with progressive MS. Unique combination of re-myelination and anti-inflammatory effect with decreased inflammatory cell infiltration. ACT-777991CXCR3 receptor antagonistVitiligo Proof-of-concept study in preparation for patients with vitiligo. Unique precision medicine with a dual targeting of CD8+ CXCR3+ T cells offers potential for a first-in-class targeted systemic therapy for effective and safer treatment of immuno-dermatology and autoimmune disorders. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet. Vaccine platform: On June 30, 2025, Idorsia announced a milestone in the development of a bacterial vaccine based on the company's synthetic glycan chemistry platform. Initial data from healthy participants showed that the vaccine, which has the potential to be the first-ever directed against Clostridioides difficile (C. difficile) bacteria and spores, is well-tolerated, and induces positive antigen titers in humans that recognize the bacteria. Idorsia will now activate partnering discussions to advance as fast as possible the development of the C. difficile vaccine and the advancement of the technology platform. Financial results US GAAP results First Half Second Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024 Net revenue 131 26 72 16 Operating expenses (75) (94) (80) (113) Operating income (loss) 64 (64) (3) (95) Net income (loss) 52 (79) (11) (109) Basic EPS 0.26 (0.44) (0.06) (0.60) Basic weighted average number of shares 195.3 179.5 203.8 179.9 Diluted EPS 0.26 (0.44) (0.06) (0.60) Diluted weighted average number of shares 195.9 179.5 203.8 179.9 Net revenue of CHF 131 million in H1 2025 resulted from QUVIVIQ product sales (CHF 56 million), product sales to partners (CHF 2 million), and contract revenues (CHF 73 million). This compares to net revenue of CHF 26 million in H1 2024 as a result of QUVIVIQ product sales (CHF 23) and contract revenue (CHF 3 million). US GAAP operating expenses of CHF 75 million in H1 2025 and CHF 94 million in H1 2024 were impacted by a one-off gain of CHF 90 million (Viatris deal amendment) in 2025 and CHF 125 million (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses at H1 2025 decreased by CHF 54 million, mainly driven by R&D expenses of CHF 50 million decreasing by CHF 21 million compared to H1 2024 (CHF 71 million), and SG&A expenses of CHF 103 million decreasing by CHF 39 million compared to H1 2024 (CHF 142 million). US GAAP net income in H1 2025 amounted to CHF 52 million (CHF 38 million net loss excluding Viatris deal amendment) and CHF 79 million (net loss) in H1 2024 (CHF 204 million net loss excluding Viatris deal). Excluding these one-offs, the reduced net loss in H1 2025 was primarily driven by revenue growth and lower operating expenses resulting from rightsizing efforts initiated at the end of 2024. The US GAAP net income resulted in a basic net income per share of CHF 0.26 (diluted net income per share of CHF 0.26) in H1 2025, compared to a basic net loss per share of CHF 0.44 (diluted net loss per share of CHF 0.44) in H1 2024. Non-GAAP* measures First Half Second Quarter in CHF millions, except EPS (CHF) and number of shares (millions) 2025 2024 2025 2024 Net revenue 130 26 72 16 Operating expenses (152) (200) (75) (104) Operating income (loss) (15) (170) 2 (85) Net income (loss) (25) (183) (1) (96) Basic and diluted EPS (0.13) (1.02) (0.00) (0.54) Basic and diluted weighted average number of shares 195.3 179.5 203.8 179.9 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in H1 2025 amounted to CHF 25 million; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris Deal (CHF 90 million). The non-GAAP net loss resulted in a net loss per share of CHF 0.13 (basic and diluted) in H1 2025, compared to a net loss per share of CHF 1.02 (basic and diluted) in H1 2024. Repurchase OfferOn June 25, 2025, Idorsia announced the launch of the repurchase offer to the holders of its outstanding CHF 200 million convertible bonds maturing in 2025 (CB 2025; ISIN CH0426820350), and CHF 600 million convertible bonds maturing in 2028 (CB 2028; ISIN CH1128004079). The main offer period of the Repurchase Offer started on July 10, 2025, and is expected to end at 17:30 hrs CEST on August 7, 2025. More information can be found in the dedicated press release. New money facilityA new money facility for a net amount of CHF 150 million has been signed and the company drew down the first tranche of CHF 70 million on June 2, 2025. This new money facility has a maturity of 24 months and is fully backstopped by a bondholder group. More information can be found in the dedicated press release. Liquidity and indebtednessAt the end of the first half of 2025, Idorsia's liquidity amounted to CHF 72 million. (in CHF millions) Jun 30, 2025 Mar 31, 2025 Dec 31, 2024 Liquidity Cash and cash equivalents 72 51 106 Total liquidity* 72 51 106 Indebtedness Convertible loan 335 335 335 Convertible bond 798 797 797 New money facility 49 - - Other financial debt 189 190 189 Total indebtedness 1,370 1,322 1,321 *rounding differences may occur Liquidity at the end of the first half of 2025 does not include the CHF 40 million milestone recognized in the second quarter from Simcere, following the amendment of the licensing agreement and the approval of QUVIVIQ in China, and the remaining CHF 80 million available under the new money facility. Financial guidance for 2025As previously announced, for the Idorsia-led portfolio in 2025, the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 130 million, COGS of around CHF 15 million, SG&A expenses of around CHF 200 million, and R&D expense of around CHF 90 million, leading to non-GAAP operating expenses of around CHF 305 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 175 million and US-GAAP operating loss of around CHF 220 million. The company expects US-GAAP EBIT for the partnered business of around CHF 165 million – and mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 55 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: Events 9-Month 2025 Financial Results reporting on October 30, 2025 Full-Year 2025 Financial Results reporting on February 26, 2026 Notes to the editor About IdorsiaThe purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10 – – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as 'intend', "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDFError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Hill
06-07-2025
- Politics
- The Hill
Trump can shatter the abortion pill cartel
The abortion pill is the only life-ending drug that does not require consultation or any assurance of accurate identifying information. In fact, for a drug that is intended to end a pregnancy, distributors do not even have to confirm pregnancy at all. Anyone not looking through the rose-colored glasses handed out by the abortion lobby can see this lack of regulation for what it clearly is: a recipe for rampant abuse. Several women have already come forward, sharing how their partner ordered the pill and drugged them, forcing abortions. Victims of sex trafficking have also come forward, recounting how they were forced to abort — often multiple times — by their captors, using the abortion pill. Somehow, these women go largely ignored by policymakers and those with the power to prevent future abuse. Abortion pill manufacturers and distributors have been allowed to form a cartel across and within the borders of the U.S. that has gone unchecked. Even those who pride themselves on giving women 'choice' should recognize there is no choice in such abuse. There is no consent in being forced to abort a wanted child. Abortion advocates' core pillar of 'autonomy' has been torn down to nothing more than rubble. As a nation, we attack the foreign cartels threatening the American people in many ways. But can we identify and shatter the ones we have allowed to form within our own borders? Since the Biden-era FDA used the COVID-19 pandemic as an excuse to remove the in-person dispensing requirement for the abortion drug mifepristone in 2021, abortion pill distributors have rapidly built their expansive cartel. Women and their abusers can access these cartel distributors online and are often required to fill out questionnaires that have no way to verify whether the alleged patient is actually the one behind the screen. Some of the questionnaires tied to these tele services ask you to confidentially verify your name and other personal identifying information. They even ask if you are being forced to order the pills. But what use are any of these questions when the abuser can easily circumvent the system and identify as the victim? In his first term, President Trump ordered one foreign abortion pill distributor to cease and desist illegal trafficking of abortion drugs not approved by the FDA into the U.S. Unfortunately, the administration did not follow through on its warning to the doctor in charge, and trafficking of the pill has only escalated. This term, the Trump administration has the opportunity and ability to send the abortion pill cartel packing. Most urgently, the Trump FDA can reinstate the in-person dispensing requirements for mifepristone. New data shows that by the end of 2024 one in four abortions were provided via 'telehealth,' demonstrating real and immediate impact reinstating REMS requirements would have. This unilateral administrative action can put a swift end to the domestic and criminal mail-order distribution of abortion pills. Although it will not prevent foreign cartel partners from sending the drugs into the country or in-person dispensing at brick-and-mortar abortion businesses, it is a first step. The Trump administration also needs to heighten scrutiny around mifepristone by working with the Department of Health and Human Services and the DEA to designate the drug as a controlled substance. Drugs with high potential for abuse and which may lead to psychological or physical damage are set to only be prescribed by certain licensed practitioners that hold DEA certifications — and mifepristone should not be an exception. Abuse of the abortion pill is rampant. Recent studies have shed further light on the expanded physical and psychological adverse events women are experiencing by taking mifepristone. Women being forced into abortion via the deregulation of the abortion pill are even more likely to experience these dangerous outcomes. The U.S. Code already creates heightened oversight and penalties for importation of controlled substances. If the Trump administration designates the abortion pill as a controlled substance, it will equip the Department of Justice to prosecute members of the cartel — both foreign and domestic — to the fullest extent of the law. Trump must also work alongside the Republican Congress to uphold state laws that prevent abortion pill trafficking. States such as Louisiana and Texas have laws in place that prohibit the abortion pill from being sent women within their borders, but it has been an uphill battle to enforce them, with pro-abortion states enacting shield laws to prevent prosecution of cartel abortionists engaging in pill trafficking. This term, Trump must hold true to abolish cartels — including the ones previous administrations have given free rein within our own borders. If Trump truly believes abortion to be a state issue, he should ensure that states have the power to protect their citizens. Women deserve to live without the paranoia that they might be the next victim of this dangerous cartel. Gavin Oxley is a public relations consultant currently serving at Americans United for Life.
Business Wire
27-06-2025
- Health
- Business Wire
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb's Cell Therapy Labels
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi ® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma ® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. $BMY announces @US_FDA has approved removal of REMS and streamlined certain patient monitoring requirements for #CARTcelltherapy treatments. Share Despite the transformative potential of cell therapy, only about 2 in 10 eligible patients receive it, due to the confluence of complex logistical and geographic barriers affecting patients and providers. BMS is committed to a long-term goal of expanding access to cell therapy and supports today's class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety. Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. These prolonged requirements posed burdens on healthcare delivery systems and for certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers. The changes include: Driving restrictions reduced from 8 weeks to 2 weeks post treatment Requirement to stay within proximity of a healthcare facility following infusion reduced from 4 weeks to 2 weeks 'CAR T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access,' said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. 'Today's FDA-approved label updates reinforce BMS' continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.' The FDA has also approved removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies. This change is likely to help further accelerate cell therapy into the community center setting. Together, these label updates reflect the growing body of clinical and real-world evidence underpinning the favorable efficacy and safety profile of CAR T cell therapy. To date, more than 30,000 patients have been treated with a CAR T cell therapy, with recent studies, including an analysis BMS presented earlier this month at the ASCO Annual Meeting, showing that the vast majority of serious adverse events (CRS and NTs) occur within the first two weeks of infusion. Following this announcement, BMS will work closely with the more than 150 treatment centers currently approved to administer Breyanzi and Abecma to remove the REMS programs. In parallel, BMS is focused on rapidly expanding the geographic footprint of cell therapy, with a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family and work. "Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future,' said Sally Werner, chief executive officer, Cancer Support Community. 'Today's announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy." As BMS continues to bring cell therapy to more patients, we are committed to working across the healthcare ecosystem to implement these label updates and continue to design and implement measurable programs to increase uptake and equitable access to cell therapy. For a list of programs and services currently offered to support patients through their BMS cell therapy journey, visit Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease. Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential. The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here. Breyanzi U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Abecma U.S. FDA-Approved Indication ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Breyanzi U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Abecma U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Warnings and Precautions: Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes. Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 10 6 CAR-positive T cells. The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS. Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 10 6 CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS. Monitor patients at least daily for 7 days following ABECMA infusion for signs or symptoms of CRS. Continue to monitor patients for signs and symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA. In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells and 300 to 460 x 10 6 CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%). At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma. Monitor patients at least daily for 7 days following ABECMA infusion for signs or symptoms of neurologic toxicities. Continue to monitor patients for signs or symptoms of neurologic toxicities for at least 2 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time. Advise patients to avoid driving for at least 2 weeks following infusion. Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia. In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved. In KarMMa, one patient treated in the 300 x 10 6 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines. Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA. Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines. Febrile neutropenia was observed in 38% (133/349) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells and 300 to 460 x 10 6 CAR-positive T cells, respectively. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines. Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL. Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dL. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA. Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared to none in the standard regimens arm at the time of the safety update. The median time to onset of myeloid neoplasm from ide-cel infusion was 338 days (Range: 277 to 794 days). Three of these five patients have died following the development of myeloid neoplasm. One out of the five cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy. Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include pyrexia, CRS, hypogammaglobulinemia, infections – pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at or follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include whether Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel) for the indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
Hans India
25-06-2025
- Business
- Hans India
RTC staff to stage protests across state on July 4 & 5
APPTD leaders submit a representation to transport commissioner and RTC MD with a list of demands which include promotions to 3,000 RTC employees, recruitment of 10,000 new staff, release of pending DA arrears and 11th PRC arrears, implementation of Retired Employees Medical Scheme among others The Andhra Pradesh Public Transport Department (APPTD) Employees' Union announced on Tuesday that it will stage statewide protests and conduct gate meetings at all 129 RTC depots on July 4 and 5. These demonstrations are a protest against the government's and RTC management's inaction in resolving their pending problems. RTC employees plan to wear red badges at the depots to express their discontent. The decision came during the APPTD state executive body meeting here, where the union discussed its long-standing grievances. The union's state meeting urged the government to immediately resolve critical issues affecting thousands of RTC employees across the state. Union leaders submitted a representation to APPTD commissioner and APSRTC vice-chairman and managing director Ch Dwaraka Tirumala Rao, detailing their demands and asking the RTC management to address them. APPTD Employees' Union president Palisetty Damodara Rao and general secretary G V Narasaiah raised several key demands. They stated that 3,000 RTC employees have been waiting for promotions for over six years and urged the RTC management to secure approval from the state government to grant these promotions. They also pressed the RTC to obtain government approval to recruit 10,000 new staff in the APSRTC and to purchase new buses. This recruitment and fleet expansion, they noted, are essential to support the implementation of the free travel facility for women from August 15, 2025, onwards. The union has also sought release of pending DA arrears and 11th PRC arrears, and immediate settlement of retirement benefits for employees, including the immediate disbursement of gratuity and leave encashment to retired personnel. Furthermore, they demanded that the RTC management implement the Retired Employees Medical Scheme (REMS) according to guidelines issued by the CEO of NTR Vaidya Vidhana Parishat Trust. They also insisted that the RTC procure electric buses directly and hand them over to APSRTC, thereby avoiding the leasing of depots to private operators. Finally, the union urged the RTC to train existing RTC staff to operate new electric buses, restore referral hospital-based medical services under the old system, offer alternative posts to medically unfit employees, and implement pending compassionate appointments.
Boston Globe
06-06-2025
- Health
- Boston Globe
Massachusetts joins three other Democrat-led states asking FDA to remove abortion pill restrictions
Advertisement Abortion pills — particularly mifepristone — have become the focus of legal battles and new legislation seeking to expand or further curtail access to the procedure since the Supreme Court overturned Roe v. Wade in 2022, and with it, the national right to abortion. Thursday's petition comes days after FDA Commissioner Marty Makary said he would conduct a review of the drug, alarming reproductive health advocates who worry the agency is gearing up to further limit access. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up A spokesperson for the Department of Health and Human Services, which includes the FDA, said HHS Secretary Robert F. Kennedy Jr. had asked Makary to review mifepristone data. The spokesperson added that Makary 'will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes.' Advertisement A large body of research shows mifepristone, first approved more than two decades ago, is safe and effective. It is used in the majority of abortions in the United States. The Democratic attorneys general asked the FDA to review the restrictions on mifepristone Thursday through a citizen petition submitted to HHS and the FDA. By law, the FDA is required to respond within 180 days of receiving the petition — granting, denying or dismissing it, or justifying why it has not reached a decision on the matter. In the month after a decision, petitioners can ask the FDA to reconsider. After that, they have the option to take the issue to court. The four attorneys general are asking the FDA to remove requirements under its Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program that mandate pharmacy certification, which involves using shippers that provide tracking and patient agreement forms for receiving the drug. They are also asking the FDA to remove prescriber certification requirements, saying the restrictions 'can discourage clinicians from offering it,' according to the petition. To prescribe mifepristone, clinicians have to send a certification form to the pharmacies their patients will visit to receive the drug. That process poses safety risks 'should such lists be leaked or compromised,' the petition says. Those risks for abortion providers are 'all the more prevalent now given the number of states that have criminalized abortion and are seeking to punish providers who have facilitated medication abortions for patients who reside in other states,' the petition says. It alludes to the first-of-its-kind prosecution this year of a New York doctor who allegedly prescribed abortion pills to a patient in Louisiana. Advertisement In a statement Thursday, James said these restrictions discourage many family medicine practices and primary care clinics from stocking or prescribing mifepristone, which particularly impacts 'rural and underserved communities' that have no alternative health-care options. According to the FDA, the Mifespristone REMS program is intended to 'mitigate the risk of serious complications' associated with the drug 'by, among other things, requiring that prescribers have the necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.' Some Republicans have been pushing the FDA to reassess the safety of mifepristone, based on a study conducted by a conservative think tank that said it found the risk of serious adverse events from taking the drug is much higher than advertised. The study is not peer-reviewed and does not reveal the database used for it. The Washington Post Fact Checker analyzed the study, which was conducted by the Ethics and Public Policy Center, and noted that it found similar rates for the most serious problems associated with abortion, such as sepsis, infection, and emergency-room visits, as are listed on the FDA-approved label of Mifeprex, the brand name for the abortion pill. According to the FDA's prescribing information on mifepristone, fewer than 0.5 percent of people taking the drug with misoprostol to end pregnancy experienced serious adverse reactions. On Thursday, the attorneys general rebuked 'recent attempts to challenge mifepristone's safety using methodologically flawed scientific research papers, noting that several of these papers have been retracted by medical journals.' Advertisement 'The coalition are urging the FDA to use this full review of mifepristone to lift unjustified restrictions and maximize access to this essential medication,' James's statement said.
