FDA Plans ODAC Review, Delays PDUFA Date for Idecabtagene Vicleucel
- Bristol Myers Squibb and 2seventy bio, Inc. today announced the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase 3 KarMMa-3 study.
- The date of the ODAC meeting has not yet been confirmed by the FDA.
- The FDA also informed the companies that a decision on the application will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.
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