<![CDATA[FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma]]>

Advertisement News|Articles|May 13, 2026 FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma Author(s)Chris Ryan Fact checked by: Ashling Wahner Listen0:00 / 0:00 Key Takeaways Accelerated approval covers relapsed/refractory MCL after ≥2 prior systemic lines, requiring prior BTK inhibitor exposure. Phase 1/2 BGB-11417-201 showed a 52% ORR (95% CI, 42%-62%) in patients previously treated with anti-CD20 therapy and a BTK inhibitor. Responses occurred quickly, with a 1.9-month median time to response, supporting activity in an aggressive, heavily pretreated population. Durability was notable, with median duration of response 15.8 months (95% CI, 7.4-not estimable) at 11.9 months’ median follow-up. Safety signals included 37% serious adverse effects; pneumonia (10%) was most common, and labeling highlights TLS, serious infections, and neutropenia.SHOW MORE The FDA granted accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma after at least 2 lines of systemic therapy. Advertisement The FDA has granted accelerated approval to sonrotoclax (Beqalzi) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a BTK inhibitor.1The approval was supported by data from the phase 1/2 BGB-11417-201 trial (NCT05471843), which showed that patients with relapsed/refractory MCL who were previously treated with an anti-CD20–based therapy and a BTK inhibitor (n = 103) experienced an overall response rate (ORR) of 52% (95% CI, 42%-62%) and a median time to response of 1.9 months. At a median follow-up of 11.9 months, the median duration of response was 15.8 months (95% CI, 7.4-not estimable).Regarding safety (n = 115), serious adverse effects were reported in 37% of patients, with the most common being pneumonia (10%). The prescribing information for sonrotoclax includes warnings and precautions for tumor lysis syndrome (TLS), serious infections, and neutropenia.Sonrotoclax dosing is recommended to begin with a 4-week ramp-up phase to reduce the risk of TLS risk, followed by 320 mg once per day until disease progression or unacceptable toxicity.ReferencesFDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma. FDA. May 13, 2026. Accessed May 13, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma NewsletterStay up to date on the most recent and practice-changing oncology dataSubscribe Now! Advertisement Related ContentAdvertisementFDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AMLByKristi RosaMay 13th 2026Tirabrutinib and CAR T-Cell Therapy Represent Potential Paradigm Shifts in R/R PCNSL ByRiley KandelMay 13th 2026Consensus Recommendations Address Key Controversies in Lymphoma ManagementByChris RyanMay 13th 2026FDA Approval Insights: Brexu-Cel for Relapsed/Refractory MCL: With Luhua (Michael) Wang, MDByLuhua (Michael) Wang, MDMay 13th 2026UCSF Receives Major Gift to Advance Research and ModernizationByUCSF HealthMay 13th 2026 Latest CMEMultimediaCommunity Practice Connections™: Empowering Interventional Radiologists in the Emerging Era of Oncolytic Immunotherapies for MelanomaYana G. Najjar, MD; Douglas B. Johnson, MD, MSCI; Rahul A. Sheth, MD, FSIR View moreVideoCommunity Oncology Connections™: Beyond Primary End Points – Digging Into Randomized and Real-World Data to Guide Challenging Treatment Decisions in HR+/HER2− Metastatic Breast Cancer | Empire State Hematology & Oncology SocietySeth A. Wander, MD, PhD; Girish Kunapareddy, MDView moreVirtual EventArkansas Association of Cancer Professionals2 Sessions are Available!View moreVideoCommunity Oncology Connections™: Beyond Primary End Points – Digging Into Randomized and Real-World Data to Guide Challenging Treatment Decisions in HR+/HER2− Metastatic Breast Cancer | South Carolina Oncology SocietySeth A. Wander, MD, PhD; Kit Lu, MDView moreVideo19th Annual New York GU Cancers Congress®Maha Hussain, MD, FACP, FASCO; Daniel P. Petrylak, MDView moreIn-Person + Virtual EventGo to PER in ChicagoMay 29-31, 2026View moreVideoCommunity Oncology Connections™: Beyond Primary End Points – Digging Into Randomized and Real-World Data to Guide Challenging Treatment Decisions in HR+/HER2− Metastatic Breast Cancer | Tennessee Oncology Practice SocietySeth A. Wander, MD, PhD; Kamel Abou Hussein, MDView moreVirtual EventIowa Oncology Society1 Session is Available!View moreVirtual EventKansas Society of Clinical Oncology1 Session is Available!View moreVideoA Case-Guided Discussion on Managing Immune Thrombocytopenic Purpura (ITP)Cindy Neunert, MD, MSCS; Hanny Al-Samkari, MD; Joseph Shatzel, MD, MCRView moreVirtual EventLouisiana Oncology Society1 Session is Available!View moreVirtual EventMissouri Oncology Society1 Session is Available!View moreVirtual EventNew Mexico Society of Clinical Oncology1 Session is Available!View moreVideoTumor Board: Expert Insights on Managing Classical 𝘌𝘎𝘍𝘙 Mutations, 𝘌𝘎𝘍𝘙 Exon 20 Insertions, and Atypical 𝘌𝘎𝘍𝘙 Mutations in Metastatic NSCLCBalazs Halmos, MD, MS; Enriqueta Felip, MD, PhD; Julia Rotow, MDView moreVideoCases & Conversations™: Transforming AML Care—Precision Strategies, Evolving Therapies, and Clinical InsightsGail J. Roboz, MD; Hagop Kantarjian, MD; Catherine Lai, MD, MPH; Amer Zeidan, MBBS, MHSView moreVideoMedical Crossfire®: Integrating Next-Generation Endocrine Targeting Therapies to Improve Outcomes for Patients With HR+/HER2- Breast CancerWilliam J. Gradishar, MD, FASCO, FACP; Laura Huppert, MD; Yuan Yuan, MD, PhDView moreVideoMedical Crossfire®: Improving Patient Outcomes in Myeloproliferative Neoplasms With Novel Therapeutic ApproachesRami Komrokji, MD; Gabriela Hobbs, MD; John Mascarenhas, MD; Naveen Pemmaraju, MDView moreVideoMedical Crossfire®: Precision Medicine in Glioma Treatment — Integration of Molecular Profiling to Inform Targeted TherapiesVinay K. Puduvalli, MD; Manmeet Ahluwalia, MD, MBA; Stephen J. Bagley, MD, MSCE; Angela Waanders, MD, MPH, MSView moreVideoMedical Crossfire®: Harnessing the Power of Modern Therapies in Newly Diagnosed Multiple MyelomaC. Ola Landgren, MD, PhD; Mohamad Mohty, MD, PhD; Surbhi Sidana, MDView moreVideoMedical Crossfire®: Expert Perspectives on Targeting c-Met Overexpression and 𝘔𝘌𝘛 Genomic Alterations in NSCLC – Unveiling the Complexities of 𝘔𝘌𝘛 DysregulationRebecca Heist, MD, MPH; Alex A. Adjei, MD, PhD, FACP; Sandip Patel, MD, FASCO; Jeremy Segal, MD, PhDView moreVideoEvolving Treatment Strategies in Pancreatic Cancer: Current Standards, Emerging Targets, and the Role of Molecular TestingEileen M. O’Reilly, MD; E. Gabriela Chiorean, MD, FASCO; Michael J. Pishvaian, MD, PhD; Brian Wolpin, MD, MPHView moreVideoGI Tumor Board—Applying Recent Advances in Biomarker Testing and Treatment in Metastatic Colorectal CancerJohn H. Strickler, MD; Stacey A. Cohen, MD; Aparna Parikh, MD; Kanwal P.S. Raghav, MBBS, MDView moreVideoCases and Conversations™: Sorting Through the Expanding Treatment Options for Patients with Relapsed/Refractory Multiple MyelomaC. Ola Landgren, MD, PhD; Mohamad Mohty, MD, PhD; Surbhi Sidana, MDView moreVideoPER Tumor Board®: Applying Recent Advances to Transform the Treatment Paradigm in SCLC—Expert Perspectives on New Approvals and Emerging StrategiesJonathan W. Goldman, MD; Percy Lee, MD, FASTRO; Erminia Massarelli, MD, PhD, MS; Misty D. Shields, MD, PhDView moreVideoBreast Cancer Tumor Board: Targeting TROP2 – Innovations in Triple-Negative Breast Cancer TreatmentJoyce O’Shaughnessy, MD; Matthew P. Goetz, MD; Hope S. Rugo, MD, FASCOView moreMultimediaEstablishing the Rationale for ADC and ICI Combinations in TNBCVirginia Kaklamani, MD, DSc; Tiffany A. Traina, MD, FASCOView moreMultimediaBreaking Down the Rationale for Targeting TROP2 in TNBCFilipa Lynce, MD; Rita Nanda, MDView moreMultimediaDissecting Clinical Trial and Real-World Data for ADCs in TNBCFilipa Lynce, MD; Rita Nanda, MDView moreMultimediaEvaluating the Latest Data and Ongoing Trials for Novel ADC Approaches in TNBCAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MDView moreMultimediaExpert Guidance on Frequently Asked Questions Regarding the Use of ADCs in TNBCAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; Virginia Kaklamani, MD, DScView moreAudioBreaking Down the Latest Clinical Data for First-line Maintenance and R/R SCLCRahul Gosain, MD, MBA; Rohit Gosain, MD; Hossein Borghaei, DO, MSView moreVideoCross-Disease Integration of Immunotherapy InnovationsGhassan Abou-Alfa, MD, MBA; Laura Williams Goff, MD, MSCI, MMHC, FASCO; Arndt Vogel, MD, PhDView moreVideoOptimizing Treatment for Biliary Tract CancersGhassan Abou-Alfa, MD, MBA; Laura Williams Goff, MD, MSCI, MMHC, FASCO; Arndt Vogel, MD, PhDView moreVideoBroadening the Frontline—Studies Informing the Use of Immunotherapy in Hepatocellular CarcinomaGhassan Abou-Alfa, MD, MBA; Laura Williams Goff, MD, MSCI, MMHC, FASCO; Arndt Vogel, MD, PhDView moreMultimediaPER Resource Center: Integrating Novel Approaches in TNBC – New Avenues for TROP2-Targeting ADCs and Beyond – NursingAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; Virginia Kaklamani, MD, DSc; Filipa Lynce, MD; Rita Nanda, MD; Tiffany A. Traina, MD, FASCOView moreVideoShow Me the Data®: New and Emerging Roles for Oral SERD Therapy in the Treatment of ER+/HER2– Breast CancerAna C. Garrido-Castro, MD; Pedram Razavi, MD, PhDView moreMultimediaExpert Roundtable and Panel Discussions: Current and Future Landscape of TNBCAditya Bardia, MD, MPH, FASCO; Erika P. Hamilton, MD; Tiffany A. Traina, MD, FASCOView moreAudioPractical Considerations and Future Directions for New Treatment Strategies in SCLCRahul Gosain, MD, MBA; Rohit Gosain, MD; Misty D. Shields, MD, PhDView moreAudioNavigating Treatment Gaps in SCLC: Relapse, Resistance, and Need for New OptionsRahul Gosain, MD, MBA; Rohit Gosain, MD; Giannis Mountzios ΜD, PhDView moreVideoMedical Crossfire® in Adjunctive Testing: Charting a New Course in Prostate Cancer Risk AssessmentJason Hafron, MD; Aaron D. Berger, MD; Arpeet Shah, MDView moreMultimediaImaging Matters: Decoding PSMA PET for Better Decision-MakingJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaWorking Together: Overcoming Barriers to Optimize Outcomes in Patients Treated With Radioligand Therapy Through Multidisciplinary CareJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Nerina McDonald, MSPAS, PA-C; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaBURST CME™ Resource Center: Integrating Novel PSMA-Directed Radioligand Approaches for Diagnosis and Management of Prostate CancerJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Nerina McDonald, MSPAS, PA-C; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaReady for Radioligand Therapy? Patient Selection and Sequencing SimplifiedJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Scott T. Tagawa, MD, MS, FACP, FASCOView moreMultimediaRadioligand Therapy 101: The Science Behind the StrategyJeremie Calais, MD, PhD; Tanya B. Dorff, MD; Scott T. Tagawa, MD, MS, FACP, FASCOView moreVideo Advances in Managing EGFR-Mutant NSCLC: Applying Evidence Across the Disease ContinuumTina Cascone, MD, PhD; Christina Baik, MD, MPH; David Planchard, MD, PhDView moreMultimediaCommunity Practice Connections™: Enhancing Melanoma Outcomes With Intratumoral Oncolytic Immunotherapy–Strategies for the Multidisciplinary TeamYana G. Najjar, MD; Sapna Patel, MDView moreVideoA New Era of Targeted Therapy for Advanced NSCLC: Exploring Future Directions for Bispecific Antibodies and ADCsSandip Patel, MD, FASCO; Myung-Ju Ahn, MD; Giannis Mountzios, MD, MSc, PhD; Zofia Piotrowska, MD, MHSView moreVideoNavigating Advances in Neovascular Retinal Disease: Translating Evidence to Practice in AMD, DME, and RVOSriniVas R. Sadda, MD, FARVO; Mark R. Barakat, MD, FASRS; David A. Eichenbaum, MD, FASRSView moreVideoEnhancing Prostate Cancer Outcomes – The Role of PSMA and Targeted Treatment StrategiesAna Kiess, MD, PhD; Erin Grady, MD, CCD, FACNM, FSNMMI; Himanshu Nagar, MD, MS; Scott T. Tagawa, MD, MS, FASCO, FACPView moreVideo(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient OutcomesMichelle L. Taylor, ANP-BC; Emely Alfaro, DNP, RN, CNS, OCN; Paige Griffith, CRNP; Beth Sandy, MSN, CRNP, FAPOView more Advertisement Advertisement Trending on OncLive1FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML2FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma3FDA Grants Breakthrough Therapy Designation to Emi-Le for Adenoid Cystic Carcinoma4AUA and SUO Amend Advanced Prostate Cancer Guideline5Dr McCann on the FDA Approval of Vepdegestrant for ESR1-Mutated, ER+ Advanced Breast Cancer