Autolus Therapeutics announces acceptance of BLA for obe-cel

Autolus Therapeutics 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. “Acceptance of the BLA filing is an important milestone for Autolus and we look forward to continuing our collaboration with the FDA during the review cycle,” commented Dr. Christian Itin, Chief Executive Officer of Autolus. “With the PDUFA date set for November, we remain focused on preparing for the potential launch of obe-cel.”