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Autologous, CAR-T, CD19

January 22, 2024

Obe-cel BLA in R/R B-ALL Accepted Although No Priority Review Was Granted

Here is a brief preview of this blast: On Monday, January 22, Autolus announced (press release) that the FDA accepted its BLA for obe-cel (AUTO1, CD19 CAR-T) BLA for the treatment of adult r/r B-ALL. Notably, the regulatory agency did not grant Priority Review, setting a PDUFA date of November 16, 2024.