2023-11-20 12:20:03
Bristol Myers Squibb and 2seventy bio provide an update on the US FDA’s review of SBLA for abecca (idecabtagene vicleucel) in earlier lines of treatment for three-class exposed relapsed or refractory multiple myeloma.
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the Supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel ).
This study follows results from the pivotal phase 3 KarMMa-3 study. The date of the ODAC meeting has not yet been confirmed by the FDA.
The companies expect the committee to review data related to the secondary endpoint of overall survival (OS).
The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard regimens, significantly reducing the risk of disease progression or death compared to standard regimens. standard in patients with RRMM exposed to three classes.
Final PFS data and interim data from the KarMMa-3 study will be presented December 11 at the 2023 American Society of Hematology (ASH) Annual Meeting and Exhibition.
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