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FDA Puts Abecma Application on Hold to Allow Advisory Committee Data Review

NEW YORK – Bristol Myers Squibb and 2seventy Bio on Monday said the US Food and Drug Administration will not make a decision on its supplemental biologics application seeking approval for Abecma (idecabtagene vicleucel) as an earlier treatment for relapsed or refractory multiple myeloma by the original Dec. 16 prescription-drug user fee date.

Instead, the agency will convene a meeting of its Oncologic Drugs Advisory Committee so that experts can review data submitted by the companies on the autologous CAR T-cell therapy from the pivotal Phase III KarMMA-3 trial.

Following the announcement, BMS's stock price was down around 2 percent at $49.80 on Monday morning on the Nasdaq. 2seventy’s stock fell around 17 percent to $1.76.

In the KarMMa-3 study, patients with advanced multiple myeloma who had previously received two to four lines of prior treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, had improved progression-free survival on Abecma compared to standard therapy. The companies expect that the ODAC will review how the cell therapy impacts overall survival, which was a secondary endpoint in KarMMa-3. The date of the meeting is not yet confirmed.

Abecma is currently approved in the US as a fifth-line treatment for patients with relapsed or refractory multiple myeloma. BMS and 2seventy have been hoping for a late 2023 FDA approval that would allow them to move Abecma to earlier lines of therapy and expand the agent’s addressable patient population from 4,000 patients to 16,000 patients in 2024. In Q2, BMS shut down one of its manufacturing facilities for the product to conduct maintenance and prepare for increased demand.

Meanwhile, 2seventy underwent a major restructuring in September. The firm had to cut its workforce by 40 percent, pause development of two early-stage targeted therapeutic programs, and shift two more programs to its partner JW Therapeutics, just so it could focus on increasing Abecma sales.