An advisory committee to the US Food and Drug Administration (FDA) has recommended the use of Abecma (idecabtagene vicleucel), a CAR-T therapy developed by Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy bio (NASDAQ: TSVT), for the treatment of triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/rMM). This recommendation supplements the therapy’s current approval for r/rMM patients who have undergone four or more prior lines of treatment.
The endorsement follows an analysis of interim overall survival data from a pivotal Phase III trial, indicating the therapy’s potential benefits for this patient population. According to the public data, similar indication extensions for Abecma are under regulatory review in Europe and Japan, highlighting the global interest in expanding access to this treatment.- Flcube.com
