CORRECTION FDA Accepts Autolus Therapeutics' Marketing Application For Obecabtagene Autoleucel For Relapsed/Refractory Adult B-cell Acute Lymphoblastic Leukemia, With Target Action Date Of November 16, 2024

Author: Benzinga Newsdesk | January 22, 2024 08:07am
Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the U.S. Food and Drug Administration (FDA) has

Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 16, 2024, a standard review timeline consistent with recently approved CAR T therapies. The FDA is not currently planning to hold an advisory committee meeting to discuss this application.

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