FDA Approves Abecma for Relapsed, Refractory Multiple Myeloma
By Lori Solomon HealthDay Reporter
TUESDAY, April 9, 2024 -- The U.S. Food and Drug Administration has approved Abecma (idecabtagene vicleucel) as a personalized CAR T-cell therapy for triple-class exposed relapsed or refractory multiple myeloma.
The approval is 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. Abecma is a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. Boxed warnings for Abecma include cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenia, and secondary hematological malignancies.
The approval was based on data from the phase 3 KarMMa-3 trial of 254 patients. At a median follow-up of 15.9 months, Abecma more than tripled the primary end point of progression-free survival versus standard regimens, with a median progression-free survival of 13.3 months versus 4.4 months (hazard ratio, 0.49). Overall response rates were also significantly improved with Abecma, with 71 percent of patients treated with Abecma achieving a response and 39 percent achieving a complete or stringent complete response compared with 42 and 5 percent, respectively, of those receiving standard regimens. Responses to Abecma were durable, with a median duration of response of 14.8 months (or 20 months for patients who derived a complete response or better).
"With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach," Al-Ola A. Abdallah, M.D., chair of the U.S. Myeloma Innovations Research Collaborative, said in a statement.
Approval of Abecma was granted to Bristol Myers Squibb and 2seventy bio.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted April 2024
Read this next
Cilta-Cel Treatment Safe, Effective for Relapsed/Refractory Multiple Myeloma
TUESDAY, Oct. 8, 2024 -- Ciltacabtagene autoleucel (cilta-cel) CAR T-cell therapy for relapsed/refractory multiple myeloma (RRMM) results in a deep and durable response, according...
Risk for Second Primary Cancer May Be No Higher With CAR T-Cell Versus Standard of Care
THURSDAY, Sept. 12, 2024 -- The overall second primary malignancy (SPM) point estimate was 5.8 percent for patients receiving chimeric antigen receptor (CAR) T-cell therapy...
FDA Approves Darzalex Faspro for Treating Multiple Myeloma
WEDNESDAY, Aug. 7, 2024 -- The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.