Tuesday, Autolus Therapeutics plc. (AUTL) announced that the European Medicines Agency has accepted the Company's Marketing Authorization Application for obecabtagene autoleucel also known as obe-cel to treat patients with relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia or ALL.
The MAA submission was based on data from the pivotal Phase 2 FELIX study of obe-cel in adult r/r B-cell ALL.
Additionally, the company mentioned that the US marketing application is currently under review with a Prescription Drug User Fee Act target action date set for November 16, 2024.
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