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Autolus Seeks FDA Approval for CAR T-Cell Therapy in B-Cell Acute Lymphoblastic Leukemia

NEW YORK – Autolus Therapeutics on Monday said it submitted a biologics license application to the US Food and Drug Administration for its CD19-directed CAR T-cell therapy obecabtagene autoleucel (obe-cel) as a treatment for patients with B-cell acute lymphoblastic leukemia.

In the Phase II FELIX trial, investigators evaluated the overall response rate in more than 100 patients with relapsed and refractory B-precursor ALL treated with obe-cel. Secondary endpoints of the trial included duration of response, minimal residual disease-negative complete response and safety.

Results from the trial presented at the American Society of Clinical Oncology's annual meeting in June showed that after a median follow-up time of 9.5 months, 54.3 percent of 94 patients who received obe-cell infusions achieved a complete response with incomplete blood count recovery. The overall response rate was 76 percent.

The London-based company also plans to submit a marketing authorization application for ob-cel in relapsed and refractory ALL to the European Medicines Agency in the first half of 2024.