Bristol Myers Squibb and bluebird bio, Inc. announced that the US Food and Drug Administration approved Abecma (idecabtagene vicleucel; ide-cel) for relapsed or refractory multiple myeloma.
Abecma is the first BCMA-directed chimeric antigen receptor (CAR) T cell immunotherapy, a one-time infusion for treating adult patients with relapsed or refractory multiple myeloma previously treated for four other therapies (immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody).
Abecma acts by binding to BCMA, a protein that is universally expressed in all the multiple myeloma cells.
Relapsed or refractory multiple myeloma patients treated with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody show low survival rates, response rate, and short response for treatment.
The approval was based on Phase II KarMMa trial of 127 patients with relapsed or refractory multiple myeloma who were previously treated with three other classes of drugs (immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody). The overall response rate was 72%, and stringent complete response was observed in 28% of patients.
The most common side effects reported were cytokine release syndrome (CRS) and neurotoxicity (NT). Cytokine release syndrome was reported in 85% of patients.
Abecma was approved after the patients were prior treated with at least four therapies.