FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy
The supplemental Biologics License Application for Abecma in this indication remains under review with the FDA; Abecma has been approved in Japan and Switzerland and received a positive CHMP Opinion by the European Medicines Agency based on KarMMa-3 Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) 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 (sBLA) for Abecma for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA. “We