Bristol: Applications Accepted in 3 Regions Globally for Abecma for Multiple Myeloma

 U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023

European Medicines Agency has validated Bristol Myers Squibb’s Type II variation application for Abecma

Bristol Myers Squibb’s supplemental New Drug Application for Abecma has also been accepted by Japan's Ministry of Health, Labour and Welfare

Applications based on interim results of Phase 3 KarMMa-3 study, the first and only randomized, controlled study designed to evaluate a CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma, in which Abecma significantly reduced the risk of disease progression or death versus standard regimens

https://finance.yahoo.com/news/regulatory-applications-accepted-across-three-105900661.html