FDA Approves BMS’s Abecma (Idecabtagene Vicleucel) for Relapsed or Refractory Multiple Myeloma
FDA Approves BMS’s Abecma (Idecabtagene Vicleucel) for Relapsed or Refractory Multiple Myeloma
Abecma (idecabtagene vicleucel) is the first approved CAR-T cell immunotherapy for relapsed or refractory (r/r) multiple myeloma.
New Drug Update
Drug Name: Abecma
Generic Name: idecabtagene vicleucel
Developer: Bristol Myers Squibb
Indication: For the treatment of triple-exposed relapsed or refractory multiple myeloma
On April 9, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma (idecabtagene vicleucel) as a personalized CAR T-cell therapy for the treatment of triple-exposed relapsed or refractory multiple myeloma.
This approval is for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is a one-time intravenous infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. Abecma’s boxed warning includes cytokine release syndrome, neurological toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenias, and secondary malignancies.
The approval was based on data from the Phase 3 KarMMa-3 trial involving 254 patients. At a median follow-up of 15.9 months, the primary endpoint of progression-free survival with Abecma was more than triple that of the standard regimen, with a median progression-free survival of 13.3 months versus 4.4 months (hazard ratio 0.49). The overall response rate was also significantly improved with Abecma treatment, with 71% of patients achieving a response, including 39% achieving a complete or stringent complete response, compared to 42% and 5%, respectively, with standard therapy. Responses to Abecma were durable, with a median response duration of 14.8 months (or 20 months for patients achieving a complete response or better).
Bristol Myers Squibb and 2seventy bio obtained the approval for Abecma.
Regulatory Approval of Abecma
In March 2020, BMS and Bluebird bio submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel, bb2121) for the treatment of adult patients with multiple myeloma.
In July 2020, the two companies resubmitted the BLA for idecabtagene vicleucel to the FDA, providing additional details on the Chemistry, Manufacturing, and Controls (CMC) module, meeting regulatory requirements raised by the FDA after the initial BLA submission in May 2020. The FDA accepted the resubmitted BLA for priority review in September 2020 and approved the therapy in March 2021.
Abecma also holds Orphan Drug and Breakthrough Therapy Designations (BTD) from the FDA, as well as PRIority MEdicines (PRIME) designation and validation of its Marketing Authorization Application (MAA) for relapsed/refractory multiple myeloma by the European Medicines Agency (EMA).
In June 2021, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Abecma for the treatment of adult patients with relapsed/refractory multiple myeloma. The European Commission (EC) granted conditional marketing authorization for Abecma in August 2021.
The Japanese Ministry of Health, Labor and Welfare approved the therapy for the treatment of adult patients with relapsed/refractory multiple myeloma in January 2022.
Content Source:康和医药