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Plus: BridgeBio’s Attruby approved for ATTR-CM, PTC’s gene therapy for AADC deficiency, and Gilead withdrew Trodelvy for urothelial cancer
By Gunjan Ohri, Data Content Analyst
December 11, 2024 12:28 AM UTC
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…
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- Source: https://www.biocentury.com/article/654425/november-s-fda-approvals-include-autolus-cd19-car-t