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Adaptive Biotechnologies Highlights New Data at 2025 ASCO Annual Meeting and EHA 2025 Congress Demonstrating How clonoSEQ® MRD Assessment is Optimizing Patient Care and Drug Development in Lymphoid Cancers
30 scientific abstracts will be presented using clonoSEQ for MRD assessment across multiple types of blood cancers SEATTLE, May 30, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan. These presentations include notable new data supporting the clinical actionability of clonoSEQ in both multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). "The breadth of new MRD evidence being shared across various blood cancer types at ASCO and EHA this year highlights the transformative impact MRD is having on clinical care and drug development," said Susan Bobulsky, Chief Commercial Officer, MRD, Adaptive Biotechnologies. "These data presentations are a testament to the central role that clonoSEQ MRD testing now plays in clinical management and drug development across lymphoid cancers, particularly when combined with several clonoSEQ data presentations in diffuse large B-cell lymphoma (DLBCL) anticipated at the 18th International Conference on Malignant Lymphoma (iCML) on June 17-21, 2025 in Lugano, Switzerland." Selected presentations include:Results from MIDAS, a phase 3 randomized study of 718 transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, demonstrate the use of MRD status to guide therapy post-induction. (ASCO Abstract 7500, June 3, 9:45-9:57 a.m. CDT, S100bc, McCormick Place Convention Center) Interim data from ADVANCE, a phase 2 randomized study of 306 transplant-eligible patients with NDMM shows the impact of MRD-guided assessments post-induction (ASCO Abstract 7503, June 3, 10:21-10:33 a.m. CDT, S100bc, McCormick Place Convention Center) Interim results from VENETOSTOP, a phase 2 study of 66 CLL patients, report the use of MRD status to shorten duration of venetoclax-based therapy. (EHA Abstract PS1568, June 14, 6:30 p.m. CEST, Poster Hall, Milano Convention Centre)Results from the phase 3 IsKia study of 151 transplant-eligible NDMM patients demonstrates increased rates of sustained MRD negativity at 10-6 with isatuximab plus carfilzomib, lenalidomide, and dexamethasone. (ASCO Abstract 7502, June 3, 10:09-10:21 a.m. CDT, S100bc, McCormick Place Convention Center) Follow-up data from PERSEUS, a phase 3 trial of 709 transplant-eligible patients with NDMM reports the impact of sustained MRD negativity status on progression free survival (PFS) with subcutaneous daratumumab plus bortezomib, lenalidomide and dexamethasone (D-VRd) induction and DR maintenance. (ASCO Abstract 7501, June 3, 9:57-10:09 a.m. CDT, S100bc, McCormick Place Convention Center) Results from DREAMM-8, a Phase 3 study in 302 patients with relapsed or refractory multiple myeloma, found superior PFS and higher MRD negativity rates in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) as compared to standard-of-care pomalidomide, bortezomib, and dexamethasone (PVd). (ASCO Abstract 7515, June 2, 9:00-9:06 a.m. CDT E450b, McCormick Place Convention Center) Data to be presented at ASCO: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia Poster Presentation6540 Initial results from a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) ± rituximab (R) + tafasitamab (tafa) for adults with newly-diagnosed (ND) Philadelphia chromosome negative (Ph-) B lymphoblastic leukemia (B-ALL) Sunday, June 19 a.m.-12 p.m. CDT Poster Presentation6543 Brexucabtagene autoleucel (Brexu-cel) as consolidation treatment in adults with B-cell acute lymphoblastic leukemia Sunday, June 19 a.m.-12 p.m. CDT Multiple Myeloma Oral Presentation7500* MRD-driven strategy following IsaKRD induction in transplant-eligible NDMM: Primary endpoints of the phase 3 MIDAS trial Tuesday, June 39:45-9:57 a.m. CDT Oral Presentation7501 Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial Tuesday, June 39:57-10:09 a.m. CDT Oral Presentation7502 Sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial) Tuesday, June 310:09-10:21 a.m. CDT Oral Presentation7503* Randomized, multi-center study of carfilzomib, lenalidomide, and dexamethasone (KRd) with or without daratumumab (D) in patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trial Tuesday, June 310:21-10:33 a.m. CDT Oral Presentation7507* Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM) Tuesday, June 311:57 a.m.-12:09 p.m. CDT Oral Presentation7515 Minimal residual disease (MRD) negativity (neg) in patients (pts) with relapsed or refractory multiple myeloma (RRMM) treated with belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd): Analysis from the DREAMM-8 trial Monday, June 29-9:06 a.m. CDT Oral Presentation7516 Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study Monday, June 29:06-9:12 a.m. CDT ASCO Oral Presentation7517* Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): Outcomes in patients with 1q21+ status in the phase 3 IMROZ study Monday, June 29:12-9:18 a.m. CDT Poster Presentation7529 Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysis Sunday, June 19 a.m.-12 p.m. CDT Poster Presentation7535 Carfilzomib, lenalidomide, and dexamethasone (KRd) as maintenance therapy after autologous stem-cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma (NDMM) Sunday, June 19 a.m.-12 p.m. CDT ASCO Poster Presentation7551* Positron emission tomography with computed tomography (PET/CT) and minimal residual disease (MRD) for efficacy assessment in transplant-ineligible newly diagnosed myeloma (Ti NDMM) patients (pts): IMROZ analysis Sunday, June 19 a.m.-12 p.m. CDT Data to be presented at EHA: Presentation Type and Number Title Presentation Timing B-Cell Acute Lymphoblastic Leukemia Oral PresentationS112 Safety and efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) b-cell acute lymphoblastic leukemia (B-ALL): results from a phase 1/2 dose expansion study Sunday, June 1511:30-11:45 a.m. CEST Oral PresentationS117 Safety and efficacy of AZD0486 in adolescent and adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia: early results from the phase 1/2 SYRUS study Friday, June 135:30-5:45 p.m. CEST Poster PresentationPF372 Donor-derived, allogeneic CD19/CD22-CAR T cells with myeloablative graft-engineered Allo-HCT for high-risk B-ALL Friday, June 136:30 p.m. CEST Chronic Lymphocytic Leukemia Poster PresentationPF575 Preliminary results of the ongoing multicenter, phase 2 study of retreatment with venetoclax plus obinutuzumab (ReVenG) in patients with recurrent chronic lymphocytic leukemia (CLL) Friday, June 136:30 p.m. CEST Poster PresentationPS1568 Using minimal residual disease status to guide venetoclax treatment duration in patients with chronic lymphocytic leukemia: interim results from the phase II VENETOSTOP study Saturday, June 146:30 p.m. CEST Follicular Lymphoma Poster PresentationPF881 Epcoritamab monotherapy demonstrates deep and durable responses at 3-year follow-up in patients with relapsed/refractory follicular lymphoma Friday, June 136:30 p.m. CEST Poster PresentationPS2150 4-year update of phase 2 ELARA trial: clinical outcomes of tisagenlecleucel in patients (pts) with high-risk relapsed/refractory follicular lymphoma (R/R FL) Saturday, June 146:30 p.m. CEST Mantle Cell Lymphoma Poster PresentationPF882 Minimal residual disease with bendamustine-rituximab with or without acalabrutinib in patients with previously untreated mantle cell lymphoma: results from the phase 3 ECHO trial Friday, June 136:30 p.m. CEST Multiple Myeloma Oral PresentationS201 Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from IMMAGINE-1 Saturday, June 145:15-5:30 p.m. CEST Oral PresentationS205* Minimal residual disease-driven strategy following isatuximab-carfilzomib-lenalidomide-dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma: Primary endpoints of the phase 3 MIDAS trial Sunday, June 1511:00-11:15 a.m. CEST Oral Presentation S207* A randomized, multi-center study of carfilzomib, lenalidomide and dexamethasone (KRd) with or without daratumumab (D) for the treatment of patients with newly diagnosed multiple myeloma (NDMM): The ADVANCE clinical trial Sunday, June 1511:30-11:45 a.m. CEST Oral PresentationS208* Analysis of sustained MRD negativity in patients with newly diagnosed multiple myeloma treated with carfilzomib-lenalidomide-dexamethasone with or without isatuximab (phase III IsKia trial) Sunday, June 1511:45 a.m.-12 p.m. CEST Poster PresentationPF727 Isa-vrd improves outcomes in high-risk (HR) newly diagnosed transplant-ineligible multiple myeloma (NDMM TI) using the IMS/IMWG consensus HR definition: results from the BENEFIT phase 3 trial (IFM 2020-05) Friday, June 136:30 p.m. CEST Poster Presentation PF729* Isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in newly diagnosed multiple myeloma (NDMM): outcomes in patients with 1q21+ status in the phase 3 IMROZ study Friday, June 136:30 p.m. CEST Poster PresentationPF750 Isatuximab, bortezomib, lenalidomide, dexamethasone (Isa-VRd) in patients with transplant-ineligible (TI) newly diagnosed myeloma (NDMM) and plasmacytomas: IMROZ subgroup analysis Friday, June 136:30 p.m. CEST Poster PresentationPF754 Interim analysis of MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after Auto-HCT in newly diagnosed multiple myeloma Friday, June 136:30 p.m. CEST Poster Presentation PS1722* Positron emission tomography with computed tomography and minimal residual disease for efficacy assessment in transplant-ineligible newly diagnosed myeloma patients: IMROZ analysis Saturday, June 146:30 p.m. CEST *Indicates data to be presented at both ASCO and EHA. About clonoSEQ clonoSEQ® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL. clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request. To review the FDA-cleared uses of clonoSEQ, visit About Adaptive Biotechnologies Adaptive Biotechnologies ("we" or "our") is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature's most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections regarding the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORS Karina Calzadilla, Vice President, Investor Relations and FP&A 201-396-1687 investors@ ADAPTIVE MEDIAErica Jones, Associate Corporate Communications Director206-279-2423media@ in to access your portfolio
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
25-02-2025
- Business
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Press Release: Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma
Sarclisa approved in Japan for patients with newly diagnosed multiple myeloma Approval offers access to new treatment options for newly diagnosed MM patients Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with VRd significantly improved progression-free survival, compared to VRd alone in transplant-ineligible newly diagnosed multiple myeloma Paris, February 25, 2025. The Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ phase 3 study. Global Head, Oncology'In recent years, new multiple myeloma cases have increased steadily in Japan and other Asian-Pacific nations, creating a need for new treatment approaches, particularly in the front-line setting. While Sarclisa-based combinations have been approved for relapsed or refractory patients in Japan, this approval represents the first indication for certain newly diagnosed patients. We are pleased to offer physicians an important new option for their patients earlier in the treatment journey, building upon our continued commitment to advancing innovative oncology treatments in difficult-to-treat hematologic malignancies around the world.' In Japan, Sarclisa was launched in August 2020 and has been approved for four different treatment regimens (in combination with pomalidomide and dexamethasone, as monotherapy, in combination with carfilzomib and dexamethasone, or in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma). In addition, Sarclisa has front-line approvals in the EU and the US. In the Asia Pacific region, Sarclisa combination regimens were also recently approved by the National Medical Products Administration in China, specifically Sarclisa-VRd in NDMM patients who are not eligible for autologous stem cell transplant, as well as Sarclisa in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with relapsed or refractory MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. About SarclisaSarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa. In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US Food and Drug Administration. Currently, Sarclisa is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple indications. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. This combination is also approved in Japan for patients with NDMM. Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous (SC) administration method for Sarclisa in clinical studies. In January 2024, Sanofi reported positive results from the IRAKLIA phase 3 study evaluating Sarclisa SC formulation administered via an on-body delivery system (OBDS) in combination with Pd compared to intravenous (IV) Sarclisa in patients with R/R MM. In December 2024, additional positive results from the program, including the GMMG-HD7 phase 3 study evaluating Sarclisa-RVd induction therapy in transplant-eligible NDMM patients, were also presented at the 66th American Society of Hematology Annual Meeting and Exposition. The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery. In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastroenteropancreatic neuroendocrine tumors and other gastrointestinal and lung cancers. For more information on Sarclisa clinical studies, please visit About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Nicolas Obrist | +33 6 77 21 27 55 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Gilbert | +1 516 521 2929 | Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Pham | +33 7 85 93 30 17 | Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans', and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press ReleaseSign in to access your portfolio
Yahoo
31-01-2025
- Business
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SNY's Sarclisa Gets EU Nod for Expanded Use in Multiple Myeloma
Sanofi SNY announced that the European Commission ('EC') has granted marketing authorization to expand the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod, Sarclisa is now approved, in combination with Velcade (bortezomib) and Bristol Myers' BMY Revlimid (lenalidomide) and dexamethasone ('VRd'), for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant. This approval was expected as the EMA's Committee for Medicinal Products for Human Use ('CHMP') issued a positive opinion recommending the approval of the Sarclisa-VRd combo in the above indication in November. The EC and CHMP decisions are based on data from the phase III IMROZ study, which evaluated Sarclisa plus standard-of-care (SOC) VRd in NDMM patients who are not eligible for transplant. The study met its primary endpoint — treatment with the Sarclisa-VRd combination reduced the risk of disease progression or death by 40% compared to VRd in the given patient population. Following this approval, Sarclisa became the first anti-CD38 therapy, in combination with VRd, for treating transplant-ineligible NDMM patients. The Sarclisa combination therapy was approved for a similar indication by the FDA in September, also supported by data from the IMROZ study. Sanofi's shares have gained over 3% in the past year against the industry's 4% decline. Image Source: Zacks Investment Research This latest EC nod marks the first approval for Sarclisain NDMM patients and the third overall approval for the drug in the region. Sarclisa, in combination with Bristol Myers' Pomalyst (pomalidomide) and dexamethasone, is approved for treating adult patients with MM who have received at least two prior therapies, including Revlimid and a proteasome inhibitor. The SNY drug is also approved in combination with Amgen's AMGN Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed/refractory MM (RRMM) who have received 1–3 prior lines of therapy. The drug is also approved for similar indications in the United States. Both Bristol Myers' Pomalyst and Revlimid have been approved for the MM space. Amgen's Kyprolis is also approved in combination with other drugs to treat certain RRMM patients. Sanofi is also evaluating Sarclisa in multiple ongoing phase II and phase III studies in combination with other current SOC therapies to treat MM across different settings. The company is also prioritizing patient comfort by evaluating a subcutaneous (SC) formulation of the drug. Earlier this month, management reported data from a late-stage study that showed that the SC formulation of Sarclisa was just as effective as the intravenous formulation of the drug in RRMM indication. The SC version is also being evaluated in various other studies across different combinations and lines of therapy. The drug's expanded use in NDMM patients is expected to boost sales in the upcoming quarters. Successful development in other MM indications would also help the company compete with J&J JNJ, whose blockbuster anti-CD38 therapy Darzalex is approved for similar use in the MM space. The J&J drug is currently approved in MM indications across different settings for use either as monotherapy or in combination with other drugs. Sanofi price | Sanofi Quote Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY) : Free Stock Analysis Report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report To read this article on click here. Zacks Investment Research Sign in to access your portfolio
