Autolus Therapeutics Celebrates FDA Approval of Clinical Trials

By Tamara Parker • Friday, January 26 15:31 • Permanent Link

Autolus Therapeutics Plc, a clinical-stage biopharmaceutical company, has reached a significant milestone with the acceptance of its biologics license application (BLA) for obecabtagene autoleucel (obe-cel) by the U.S. Food and Drug Administration (FDA). The BLA submission is intended for the treatment of patients with relapsed/refractory (R/R) adult B-cell acute lymphoblastic leukemia (ALL). The FDA has set a target action date of November 16, 2024, under the Prescription Drug User Fee Act (PDUFA).

Dr. Christian Itin, Chief Executive Officer of Autolus, highlighted the importance of this milestone, stating, "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. With the PDUFA date set for November, we remain focused on preparing for the potential launch of obe-cel."

Additionally, Autolus plans to submit a marketing authorization application for obe-cel to the European Medicines Agency (EMA) in the first half of 2024. Obe-cel has received orphan drug designation by the FDA, orphan medical product designation by the EMA, regenerative medicine advanced therapy (RMAT) designation by the FDA, and priority medicines (PRIME) designation by the EMA for adult R/R B-ALL.

Autolus Therapeutics is known for developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. The company utilizes a broad suite of proprietary and modular T cell programming technologies to engineer precisely targeted, controlled, and highly active T cell therapies.

The company's shares have experienced a slight decrease of -0.5%, trading at a price of $5.92.

For more information, the company's full 8-K submission is available here.

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