Health Canada approves Novartis' KISQALI® for HR+/HER2- early breast cancer patients at high risk of recurrence
Despite endocrine therapy (ET), the risk of recurrence for people diagnosed with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early breast cancer (eBC) remains high, in addition to the possibility of an incurable metastatic relapse.1
Health Canada approval is based on the pivotal Phase III NATALEE trial data, which demonstrated a clinically meaningful invasive disease-free survival (iDFS) benefit for KISQALI® plus adjuvant aromatase inhibitor (AI) in patients with stage II or III HR+/HER2- eBC.2
KISQALI is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival in three Phase III trials in advanced breast cancer.3,4,5
MONTREAL, June 18, 2025 /CNW/ - Novartis Canada is pleased to announce that Health Canada has granted a Notice of Compliance (NOC) for KISQALI® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II-III early breast cancer (eBC) at high risk of recurrence.2
Breast cancer is one of the most common cancers globally,6 with HR+/HER2- being the most prevalent subtype, accounting for approximately 70% of cases.7,8,9 Over 40% of HR+/HER2- breast cancer cases are diagnosed at stage II or III, with a high risk of recurrence for up to 20 years.8,9 If cancer recurs, it is often metastatic which in most cases is considered incurable.10,11 This progression significantly increases the burden on patients, caregivers, and healthcare systems, both financially and emotionally.11,12 On average, 15 Canadian women will die from breast cancer every day.13
"Over our years supporting younger patients, we've seen far too many with HR+ breast cancer become metastatic even while on maintenance endocrine therapy," said MJ DeCoteau, Founder and Executive Director, Rethink Breast Cancer. "Breast cancer is often more aggressive in younger patients, and they have higher rates of recurrence despite early treatment. So, we were thrilled to see that the positive results for KISQALI for early breast cancer are the same for patients of all ages, regardless of stage and nodal status. Our community desperately wants more effective tools to help improve their chances against this challenging disease that's turned their life plans upside-down. This Health Canada approval is an exciting step forward."
The Health Canada approval is based on the global Phase III NATALEE trial, which included a broad patient population with HR+/HER2- stage II and III eBC. At the final analysis, this clinical trial demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence with ribociclib plus AI compared to AI alone. Among patients with stage II and stage III eBC, ribociclib added to AI demonstrated a 25.1% relative reduction in the risk of an invasive disease-free survival (iDFS) event compared with AI alone,1 with a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial.2,4,14,15
"In the NATALEE trial, ribociclib demonstrated significant efficacy for a broad population of patients with early breast cancer,"2 said Dr. Stephen Chia, Medical Oncologist, BC Cancer and Steering Committee member of the NATALEE trial. "This approval provides a new and expanded treatment option for these patients to help reduce their risk of cancer returning. Patients deserve access to the most effective treatment options, and their individual needs should always be at the centre of shared decision making. In every situation, it's critical to have an open, balanced risk-benefit discussion, in order to make the appropriate treatment decision that's best suited for the patient to reduce the risk of their cancer returning."
"While the risk of cancer returning peaks in the first five years after diagnosis, more than half of recurrences occur after this period, and the majority are metastatic and incurable,"16,17 said Dr. Katarzyna Jerzak, Medical Oncologist, Sunnybrook Health Sciences Centre. "Ribociclib provides a new treatment option to help reduce the risk of recurrence and improve outcomes, particularly for patients at elevated risk. This approval expands our treatment arsenal with a targeted therapy that will have a meaningful impact on improving the care of patients diagnosed with early breast cancer in Canada."
"Novartis has been advancing innovative research and medical practice in breast cancer care for over 35 years, developing one of the most comprehensive pipelines in the field. Over 100,000 people with HR+/HER2- metastatic breast cancer have been treated with KISQALI globally,18 and now we're focused on expanding its use to those with stage II or III HR+/HER2- early breast cancer to reduce risk of recurrence," said Mark Vineis, Country President, Novartis Canada. "We are actively committed to working with our health system partners to ensure timely access to KISQALI and supporting Canadians and healthcare professionals to improve health outcomes."
About early breast cancer (eBC)Breast cancer is the most commonly diagnosed cancer among Canadian women, with approximately 70% of cases diagnosed in the early stages of the disease.7,8,11 However, despite existing treatment options, people with stage II and III HR+/HER2- eBC remain at significant risk of recurrence.11,12
The risk of recurrence is influenced by factors such as lymph node involvement, tumor size, age at diagnosis, and biomarkers. While patients without lymph node involvement typically have a lower risk, nearly 25% of those with HR+/HER2- eBC may experience recurrence within 20 years,1 peaking after the first five years.19 However, more than half of recurrences still happen after five years and more than 80% of these cases are metastatic and incurable.20
About KISQALI® (ribociclib tablets)KISQALI was previously approved by Health Canada on March 2, 2018, for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer.20
KISQALI is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.2
In eBC, KISQALI is the only CDK4/6 inhibitor recommended for both all node-positive disease and patients with no nodal involvement with high-risk disease characteristics.20,21 The National Comprehensive Cancer Network (NCCN) guidelines recommend ribociclib (KISQALI) as a Category 1 preferred CDK4/6 inhibitor for breast cancer patients.21 KISQALI, in combination with an AI, has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment of adults with stage II and III HR+/HER2- eBC, at high risk of recurrence.22
The most common Adverse Drug Reactions across the NATALEE study (>20% and exceeding the frequency for AI alone) were neutropenia (62.5% vs. 4.6%), infections (36.3% vs. 26.3%), nausea (23.3% vs.7.8%, headache (23.0% vs. 17.1%), fatigue (22.3% vs. 13.2%), leukopenia (22.3% vs. 3.6%), and abnormal liver function tests (22.3% vs. 7.6%).2
Please see the Product Monograph for KISQALI, available at https://www.novartis.com/ca-en/kisqalimonograph.
About NATALEENATALEE is a global Phase III multi-centre, randomized, open-label trial to evaluate the efficacy and safety of KISQALI with an AI as an investigational adjuvant treatment versus AI alone in patients with stage II and III HR+/HER2- eBC. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin, if applicable. The primary endpoint of NATALEE was invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria. A total of 5,101 adult patients with HR+/HER2- eBC across 20 countries were randomized in the trial.13,23
About NovartisNovartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit www.novartis.ca.
References
________________________________1 Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years (incl. supplementary appendix). N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830
2 Novartis. (2025). KISQALI Product Monograph. Accessed June 2025. https://www.novartis.com/us-en/sites/novartis_us/files/kisqali.pdf
3 Hortobagyi G, Stroyakovskiy D. Yardley DA, et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial. Presented at: San Antonio Breast Cancer Symposium 2023 on December 5–9, 2023 San Antonio, TX.
4 Bardia A, Hortobagyi GN, Lipatov O, et al. LBA23: Invasive disease–free survival (iDFS) across key subgroups from the Phase III NATALEE study of ribociclib (RIB) + a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC). Presented at: European Society for Medical Oncology (ESMO) Congress on 23 October 2023. Madrid, Spain.
5 Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer: primary results from the Phase III NATALEE trial. Presented at: the American Society of Clinical Oncology Annual Meeting on June 2, 2023. Chicago, USA.
6 International Agency for Research on Cancer (IARC). Accessed April 2025. https://gco.iarc.fr/today/en/dataviz/pie?mode=cancer&group_populations=1.
7 American Cancer Society. Breast Cancer Facts & Figures 2019-2020. 2019. Accessed April 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf.
8 Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055. doi:10.1093/jnci/dju055
9 Criscitiello C, Spurden D, Piercy J, et al. Health-Related Quality of Life Among Patients With HR+/HER2- Early Breast Cancer. Clin Ther. 2021;43(7):1228-1244.e4. doi:10.1016/j.clinthera.2021.04.020
10 Mayo Clinic. Recurrent breast cancer. July 2, 2022. Accessed April 2025. https://www.mayoclinic.org/diseases-conditions/recurrent-breast-cancer/symptoms-causes/syc-20377135.
11 Breast Cancer Now. Breast cancer recurrence. May 2019. Accessed April 2025. https://breastcancernow.org/about-breast-cancer/diagnosis/breast-cancer-recurrence/.
12 FDA Approval. Available from https://www.novartis.com/news/media-releases/fda-approves-novartis-kisqali-reduce-risk-recurrence-people-hrher2-early-breast-cancer. Accessed April 2025
13 Government of Canada. Breast cancer in Canada. Accessed June 2025. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/breast-cancer.html
14 Slamon D et al. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024;390:1080-1091. doi: 10.1056/NEJMoa2305488
15 Yardley D, Untch M, et al. Baseline (BL) characteristics and efficacy endpoints for patients (pts) with node-negative (N0) HR+/HER2− early breast cancer (EBC) in NATALEE. Presented at the American Society of Clinical Oncology Annual Meeting; May 31, 2024; Chicago, USA.
16 Geurts YM, Witteveen A, Bretveld R, et al. Patterns and predictors of first and subsequent recurrence in women with early breast cancer. Breast Cancer Res Treat. 2017;165(3):709-720. doi:10.1007/s10549-017-4340-3
17 Wangchinda P, Ithimakin S. Factors that predict recurrence later than 5 years after initial treatment in operable breast cancer. World J Surg Oncol. 2016;14(1):223. Published 2016 Aug 24. doi:10.1186/s12957-016-0988-0
18 Novartis Data on File.
19 Bushnell GG, Deshmukh AP, den Hollander P, et al. Breast cancer dormancy: need for clinically relevant models to address current gaps in knowledge. NPJ Breast Cancer. 2021;7(1):66. Published 2021 May 28. doi:10.1038/s41523-021-00269-x
20 Health Canada Approval. Available from https://www.newswire.ca/news-releases/health-canada-approves-kisqali-for-the-treatment-of-hr-positive-and-her2-negative-metastatic-breast-cancer-in-postmenopausal-women-in-combination-with-letrozole-as-an-initial-endocrine-based-therapy-681481661.html. Accessed April 2025
21 NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Accessed May 2025. https://www.nccn.org
22 European Society of Medical Oncology (ESMO). ESMO MCBS scorecards; NATALEE. Available at https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards/scorecard-468-1. Accessed April 2025.
23 Clinicaltrials.gov. NCT03701334. A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/ HER2- Early Breast Cancer (NATALEE). Updated October 10, 2024. Available at https://clinicaltrials.gov/study/NCT03701334. Accessed April 2025
SOURCE Novartis Pharmaceuticals Canada Inc.
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Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; the risk that physicians may not see the benefits of prescribing Yeztugo for PrEP; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at Advancing Access, Truvada, Truvada for PrEP, Yeztugo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ Sign in to access your portfolio
Business Wire
2 hours ago
- Business Wire
Incyte Announces FDA Approval of Monjuvi ® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). "Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without substantial increase in side effects. Based on the data from the inMIND trial of Monjuvi, today's approval brings to this patient population the first CD-19 and CD20-targeted immunotherapy combination and a potential new treatment standard,' said Hervé Hoppenot, Chief Executive Officer, Incyte. 'This second U.S. approval for Monjuvi reinforces our commitment to advancing innovation for the lymphoma community.' The Priority Review and FDA approval of the supplemental Biologics License Application (sBLA) for Monjuvi was based on data from the pivotal, randomized, double-blind, placebo-controlled Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi in combination with rituximab and lenalidomide in adult patients with relapsed or refractory FL. Data from the trial was featured in the Late-breaking Session (LBA-1) at the 2024 American Society of Hematology (ASH) Annual Meeting. 1 The study met its primary endpoint demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment, which demonstrated 27.5% (N=273) of patients with an event in the Monjuvi group vs. 47.6% (N=275) of patients with an event in the control arm. Patients receiving Monjuvi in combination with rituximab and lenalidomide achieved a median PFS by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The PFS assessed by an Independent Review Committee (IRC) was consistent with investigator-based results. Median PFS by IRC was not reached (95% CI, 19.3-NE) in the Monjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the control arm (HR: 0.41 [95% CI, 0.29-0.56]. The PFS benefit was consistent across prespecified patient subgroups, including number of previous lines of therapy. The safety of Monjuvi in patients with FL was evaluated in 546 patients in the inMIND trial. Serious adverse reactions occurred in 33% of patients who received Monjuvi in combination with rituximab and lenalidomide, including serious infections in 24% of patients (including pneumonia and COVID-19 infection). Other serious adverse reactions in ≥ 2% of patients included renal insufficiency (3.3%), second primary malignancies (2.9%), and febrile neutropenia (2.6%). Fatal adverse reactions occurred in 1.5% of patients, including from COVID-19, sepsis, and adenocarcinoma. The most common adverse reactions (≥ 20%) in recipients of Monjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 laboratory abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes. 'Follicular lymphoma is generally an indolent yet chronic cancer that frequently recurs after treatment, making long-term disease control a critical objective,' said Christina Poh, M.D., Assistant Professor of Medicine at the University of Washington and Fred Hutchinson Cancer Center. 'The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease.' FL is the second most common type of non-Hodgkin lymphoma (NHL) and represents up to 30% of NHL cases. 2 While considered an indolent, slow-growing disease with prolonged survival, FL is challenging to treat due to its tendency for frequent relapse, need for multiple lines of therapy and potential transformation into large B-cell lymphoma. 2,3 'While the initial responses to FL treatment are often positive, recurrence can become increasingly difficult for patients to manage as they navigate emotions and the next treatment steps related to relapse,' said Mitchell Smith, M.D., Ph.D., Chief Medical Officer, Follicular Lymphoma Foundation. "We are pleased that the FDA has approved tafasitamab, part of a treatment combination offering a new option for patients living with this chronic disease.' In July 2020, Monjuvi in combination with lenalidomide received FDA approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication was approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval of Monjuvi for this indication may be contingent on verification and description of clinical benefit in confirmatory trial(s). Tafasitamab is also being evaluated as a therapeutic option in an ongoing pivotal trial for first-line DLBCL. Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Monjuvi have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering personalized patient support, including financial assistance and ongoing education and additional resources. More information about IncyteCARES is available by visiting or calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET. About inMIND A global, double-blind, randomized, controlled Phase 3 study, inMIND (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years). The primary endpoint of the study is progression-free survival (PFS) by investigator assessment in the FL population, and the key secondary endpoints are PFS in the overall population as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. For more information about the study, please visit About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the U.S., Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. XmAb® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the 'triangle' design are registered trademarks of Incyte. IMPORTANT SAFETY INFORMATION What are the possible side effects of MONJUVI? MONJUVI may cause serious side effects, including: Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or any bruising or bleeding Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 °F (38 °C) or above, or develop any signs or symptoms of an infection The most common side effects of MONJUVI when given with lenalidomide in people with DLBCL include: respiratory tract infection feeling tired or weak diarrhea cough fever swelling of lower legs or hands decreased appetite The most common side effects of MONJUVI when given with lenalidomide and rituximab in people with FL include: respiratory tract infections diarrhea rash feeling tired or weak muscle and bone pain constipation cough These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects. Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you Have an active infection or have had one recently Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby You should use an effective method of birth control (contraception) during treatment and for 3 months after your last dose of MONJUVI Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with MONJUVI Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment and for at least 3 months after your last dose of MONJUVI You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation. Tell your healthcare provider about all the medications you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements. Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Incyte Medical Information at 1-855-463-3463. Please see the full Prescribing Information including the Medication Guide for Monjuvi. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether Monjuvi may provide a successful treatment option for patients with FL, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of the United States; the efficacy or safety of Incyte and its partners' products; the acceptance of Incyte and its partners' products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2024 and its quarterly report on form 10Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.
