Autolus Seeks FDA OK of Obe-Cel in Adult B-Cell Acute Lymphoblastic Leukemia
27 Novembre 2023 - 1:54PM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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