NEW YORK – The US Food and Drug Administration on Thursday approved Bristol Myers Squibb and 2seventy bio's autologous CAR T-cell therapy Abecma (idecabtagene vicleucel) for patients with relapsed or refractory multiple myeloma who have previously received two or more lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The FDA based its decision on the results of the Phase III KarMMa-3 clinical trial, in which the B-cell maturation antigen (BCMA)-directed CAR T-cell therapy led to a statistically significant improvement in progression-free survival versus standard of care. Patients randomized to receive Abecma lived for a median of 13.3 months without their cancers progressing, whereas patients who received one of several standard-of-care regimens lived a median of 4.4 months without their cancers progressing. Although Abecma did not significantly improve overall survival compared to the standard of care, more than half of the patients in the comparator arm — 56 percent — crossed over to Abecma after their cancer progressed, which confounded the overall survival analysis.
The FDA's decision to approve Abecma in this earlier-line setting aligns with its Oncologic Drugs Advisory Committee (ODAC)'s view of the risk-benefit profile of the drug. After considering data from KarMMa-3, the committee members voted 8 to 3 last month that Abecma's benefits outweighed its risks, despite the higher risk of early deaths seen in the Abecma arm. At that same meeting, ODAC members debated the same question for Janssen's BCMA-directed multiple myeloma CAR T-cell therapy Carvykti (ciltacabtagene autoleucel).
In a statement on Friday announcing the FDA approval, BMS said it is putting resources into increasing its ability to manufacture Abecma and touted a 94 percent manufacturing success rate for Abecma in the commercial setting.
Abecma has already garnered approvals in this earlier-line multiple myeloma setting in Japan, Switzerland, and the European Union.