FDA delays review of sBLA for Abecma for earlier use

Shares of US pharma major Bristol Myers Squibb (NYSE: BMY) fell more than 4% pre-market and partner 2seventy bio (Nasdaq: TSVT) was down 17.6% at $1.76 on Monday, after the companies said the US Food and Drug Administration would miss its target date for potential approval of earlier use of a cancer therapy Abecma (idecabtagene vicleucel).

The FDA said its Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase III KarMMa-3 study.

The date of the ODAC meeting has not yet been confirmed by the FDA, but the agency 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. Abecma is already approved for treatment of relapsed or refractory multiple myeloma.