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# Abecma Expanded Approval for Multiple Myeloma
- URL: https://www.fdaweb.com/abecma-expanded-approval-for-multiple-myeloma/
- Published: 2024-04-05T12:00:00.000Z
- Updated: 2026-09-14T14:27:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156715

FDA has approved a Bristol Myers Squibb and 2Seventy Bio supplemental BLA for Abecma (idecabtagene vicleucel; ide-cel) for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody. The approval, which is based on results from the KarMMa-3 trial, expands the therapy’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy, according to the companies.

While treatments have advanced over time, multiple myeloma still remains an incurable disease that includes periods of remission and relapse. “In early lines of treatment, regimens consisting of combinations of IMiDs, PIs, and anti-CD38 monoclonal antibodies are often used to help manage the disease,” according to the companies. “Unfortunately, as many patients go on to relapse and/or become refractory to these classes of therapy, more patients are becoming triple-class exposed earlier in their treatment journey. There are limited options for these patients, and triple-class exposed relapsed and/or refractory multiple myeloma is associated with poor outcomes and a median progression-free survival (PFS) of three to five months.”

Abecma has shown statistically significant improvements in PFS in this patient population, they note, adding that the therapy has exhibited a well-established safety profile with mostly low-grade cytokine release syndrome and neurotoxicity.