Autolus Therapeutics To Review BLA For Obe-cel - Quick Facts

(RTTNews) - Autolus Therapeutics plc (AUTL) said the FDA has accepted its Biologics License Application or BLA for obecabtagene autoleucel or obe-cel for patients with relapsed/refractory Adult B-Cell Acute Lymphoblastic Leukemia. The FDA has set a target action date of November 16, 2024. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss the application. The BLA submission is based on data from the Phase 2 FELIX study of obe-cel in adult r/r B-ALL.

Christian Itin, CEO of Autolus, said: "With the PDUFA date set for November, we remain focused on preparing for the potential launch of obe-cel."

Autolus plans to submit a Marketing Authorization Application for obe-cel in relapsed/refractory ALL to the European Medicines Agency in the first half of 2024.

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