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Autologous, CAR-T, CD19

January 31, 2024

Breyanzi Regulatory Applications for R/R FL and R/R MCL Accepted in the US and Japan

Here is a brief preview of this blast: On Tuesday, January 30, BMS announced (press release) that the Breyanzi (CD19 CAR-T) sBLAs for r/r FL and r/r MCL have been accepted by the FDA with projected PDUFA dates on May 23, 2024, and May 31, 2024, respectively. Additionally, the application for Breyanzi in r/r FL has also been validated in Japan.