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
Persistent Sociodemographic Differences Seen in Use of AutoHCT for Multiple Myeloma
WEDNESDAY, May 8, 2024 -- Sociodemographic differences persist in utilization of autologous hematopoietic cell transplantation (autoHCT) for multiple myeloma, according to a study...
Survival 21 Percent a Year After ICU Discharge for Blood Cancer Patients
THURSDAY, March 21, 2024 -- For hematologic malignancy (HM) patients admitted to the intensive care unit (ICU), survival is 49 percent at seven days and 21 percent at 12 months...
Triplet Therapy Including Belamaf Prolongs Survival in Multiple Myeloma
FRIDAY, Feb. 9, 2024 -- For patients with relapsed or refractory multiple myeloma (RRMM), triplet therapy of belantamab mafodotin (belamaf) plus bortezomib and dexamethasone (BVd)...
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.