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CHMP Backs BMS and 2seventy’s Abecma for Earlier-Stage Multiple Myeloma Treatment

NextEdge Admin

31 Jan 2024

2 min 13 sec

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol Myers Squibb’s autologous CAR T-cell therapy, Abecma (idecabtagene vicleucel), as a third-line treatment for patients with relapsed or refractory multiple myeloma. Specifically, the committee suggests approval for patients who have undergone at least two prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

In the Phase III KarMMa-3 clinical trial, Abecma demonstrated improved progression-free survival compared to standard-of-care treatments for multiple myeloma patients who had received between two and four prior therapies. With a median follow-up of 30.9 months, patients treated with Abecma experienced a median progression-free survival of 13.8 months, representing a 51 percent reduction in disease progression or death compared to those on standard regimens (4.4 months).

While Abecma is already approved as a fifth-line treatment for relapsed or refractory multiple myeloma in the US, its approval for an earlier-line indication is pending as the FDA reviews the KarMMa-3 data. In Europe and Japan, Abecma is already approved for use in later-line settings. The European Commission is set to review CHMP’s recommendation for Abecma’s earlier-line use, with a decision expected in approximately two months. Bristol Myers Squibb jointly markets Abecma with 2seventy Bio in the US, while BMS solely handles its distribution in ex-US markets.