TSVT - FDA Adcomm Favors Expanded Use Of Johnson & Johnson Bristol Myers' CAR-T Therapies For Type Of Blood Cancer | Benzinga
Friday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) favoring expanded use of Bristol Myers Squibb & Co (NYSE:BMY) 2seventy bio Inc’s (NASDAQ:TSVT) Abecma (idecabtagene vicleucel).
The panel said Abecma demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on the pivotal Phase 3 KarMMa-3 study results, including the key secondary endpoint of overall survival.
The FDA will consider the recommendation from the ODAC 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 the review of the sBLA, which was postponed from the target action date of December 16, 2023.
Abecma was recently approved in Japan and ...