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Eight PDUFA dates on deck in April


J&J and Legend’s CAR T therapy could move into earlier lines; Day One could get its first marketed product

By Gunjan Ohri, Data Content Analyst

March 28, 2024 11:51 PM UTC

The eight disclosed PDUFA dates on FDA’s April calendar include an application to move BCMA-targeted CAR T cell therapy Carvykti into earlier-line treatment of multiple myeloma.

FDA has set a target action date of April 5 on an sBLA seeking approval of Carvykti ciltacabtagene autoleucel from Johnson & Johnson (NYSE:JNJ) and Legend Biotech Corp. (NASDAQ:LEGN) for second-line treatment of multiple myeloma…