Autolus Therapeutics announces positive CHMP opinion for obe-cel

Autolus Therapeutics (AUTL) announces that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has recommended European Commission, EC, approval of obecabtagene autoleucel, obe-cel, for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. “This positive opinion from the CHMP highlights the significant unmet need and importance of effective treatment options for adult r/r B-ALL,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “With FDA approval received in November 2024 and an MHRA conditional marketing authorization received in April 2025, we are on our way to bringing this therapy to patients in need globally.”