Bristol Myers Squibb: FDA to review data

(CercleFinance.com) - Bristol Myers Squibb and 2seventy bio have provided an update on the US FDA's review of the SBLA for abecca (ipecabtagene vicleucel) in prior lines of treatment for relapsed or refractory multiple myeloma exposed to three classes.


The FDA's Oncologic Drugs Advisory Committee (ODAC) will meet to review the data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagen vicleucel).

This study follows the results of the pivotal phase 3 KarMMa-3 study. The date of the ODAC meeting has not yet been confirmed by the FDA.

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 in patients with three classes of exposed RRMM.

Final PFS data and interim data from the KarMMa-3 study will be presented on 11 December at the American Society of Hematology (ASH) 2023 Annual Meeting and Exposition.


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