Obe-cel Receives FDA Approval for Relapsed, Refractory B-ALL

Obecabtagene autoleucel (obe-cel) received FDA approval for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), according to a press release from Autolus Therapeutics, the manufacturer of the chimeric antigen receptor T-cell therapy.

The approval is based on results of the FELIX trial, which evaluated the safety and efficacy of obe-cel. In 65 efficacy-evaluable patients, 51% achieved complete remission (CR) at any time and 12% achieved CR with incomplete hematologic recovery at any time. Forty-two percent achieved CR at three months, and the median duration of remission was 14.1 months.

Grade 3 cytokine release syndrome occurred in 3% of patients; there were no Grade 4 or 5 events. Grade 3 or higher immune effector cell-associated neurotoxicity syndrome occurred in 7% of patients.

“Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes,” Elias Jabbour, MD, a Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center and lead investigator of the FELIX study, said in the press release. “This milestone approval, based on the demonstrated clinical benefit of [obe-cel], brings new hope for adult patients with relapsed or refractory B-ALL.”

Read more: Dr. Shaughnessy Outlines FELIX Trial of Obe-Cel in Relapsed, Refractory B-ALL