A regulatory decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.
The FDA plans to hold a meeting of the Oncologic Drugs Advisory Committee to review data supporting Bristol Myers Squibb’s supplemental biologics license application (sBLA) for Abecma (idecabtagene vicleucel). BMS and partner 2seventy bio are seeking approval of Abecma to treat earlier lines of relapsed or refractory multiple myeloma (RRMM). The date of the ODAC meeting has not yet been set. As a result, a decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.
The companies said in a press release that they expect the advisory committee will review data related to the secondary endpoint of overall survival from the phase 3 KarMMa-3 study, which met its primary endpoint of improvement in progression-free survival (PFS) compared with standard regimens and reducing the risk of disease progression or death.
Abecma is currently approved for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy. It is a B-cell maturation antigen (BCMA)-directed CAR-T cell immunotherapy. It binds to BCMA, a protein that is expressed on cancer cells in multiple myeloma.
The supplemental application was based on the phase 3 KarMMa-3 study, which enrolled 254 patients treated with Abecma and 132 patients treated with standard regimens; results were published earlier this year in The New England Journal of Medicine. At a median follow up of 18.6 months, treatment with Abecma results in a median progression-free survival of 13.3 months compared with 4.4 months for patients on standard care. This represents a 51% reduction in risk of disease progression or death with Abecma.
The overall response rate also met statistical significance with the majority of patients (71%) treated with Abecma achieving a response, and 39% achieving a complete response or stringent complete response. In comparison, less than half of patients (41%) who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response. The median duration of response was 14.8 months for those treated with Abecma compared with 9.7 months for standard regimens.
In patients treated with Abecma, 88% experienced any grade cytokine release syndrome, with grade 3/4 events occurring in 4% of patients. Two patients (1%) experienced a grade 5 cytokine release syndrome event. Any grade neurotoxicity occurred in 15% of patients, with grade 3/4 neurotoxicity occurring in 3% of patients, and no grade 5 events reported.
Final progression-free survival data and interim overall survival data from the KarMMa-3 study will be presented on Dec. 11, 2023, at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition.