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.
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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).
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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.
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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.