The US Food and Drug Administration (FDA) has postponed the target action date for Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy Bio (NASDAQ: TSVT)’s CAR-T cell therapy Abecma (idecabtagene vicleucel) from December 16. The decision affects the therapy’s filing for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (r/r MM). The delay is attributed to the regulator’s request for a meeting to review data from a pivotal Phase III study, potentially concerning the secondary endpoint of overall survival (OS), as the trial has already met its primary endpoint of progression-free survival (PFS) and demonstrated an acceptable safety profile.
European and Swiss Regulatory Reviews for Abecma
Parallel to the US, regulatory agencies in Europe and Switzerland are currently reviewing submissions for Abecma for the same indication. The therapy is already approved in the US for triple-class exposed r/r MM patients who have undergone four or more prior lines of therapy.- Flcube.com
