Breyanzi’s sNDA Accepted in Japan for 2L DLBCL
On Friday, March 25, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted Breyanzi’s (CD19 CAR-T) sNDA for 2L DLBCL. Of note, the acceptance is based on results from Breyanzi’s Ph3 TRANSFORM trial. The Celltelligence team will be conducting a full thoughts-on analysis and provide potential approval timelines in the coming days.