November’s FDA approvals include Autolus’ CD19 CAR T 

In November, FDA approved at least 10 new NDAs and BLAs, including a CD19 CAR T cell therapy from Autolus and a TTR stabilizer from BridgeBio. 

Autolus Therapeutics plc (NASDAQ:AUTL) received its first FDA approval with Aucatzyl obecabtagene autoleucel, a CD19 CAR T cell therapy, for B cell acute lymphoblastic leukemia. In a the pivotal FELIX trial, Aucatzyl led to an objective response rate of 78%, with a median follow-up of 21.5 months. In initial data, 42% of patients achieved complete remission within 3 months...