Bristol Myers, 2seventy Bio: FDA’s ODAC votes in favor of Abecma

Bristol Myers Squibb (BMY) and 2seventy bio (TSVT) announced that the U.S. FDA Oncologic Drugs Advisory Committee voted positively (8-3) that Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival. The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application for Abecma for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA.