Tag Archives: MHLW

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.

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