Autolus Seeks FDA OK of Obe-Cel in Adult B-Cell Acute Lymphoblastic Leukemia

By Colin Kellaher

Autolus Therapeutics has filed for U.S. Food and Drug Administration approval of obecabtagene autoleucel, its lead investigational chimeric antigen receptor T-cell, or CAR-T, therapy, for adult relapsed/refractory B-cell acute lymphoblastic leukemia.

The London-based clinical-stage biopharmaceutical company on Monday said it is also on track to submit a marketing authorization application for the therapy, also known as oba-cel, to the European Medicines Agency in the first half of 2024.

Autolus said its FDA filing is based on data from a pivotal Phase 2 study of oba-cel in patients with the cancer that affects the blood and bone marrow.

Autolus in June said the study had met its primary endpoint, with 76% of dosed patients achieving a complete response or complete response with incomplete haematological recovery.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 27, 2023 07:39 ET (12:39 GMT)

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