Autolus Therapeutics plc (AUTL) announced that the European Medicines Agency's
Committee for Medicinal Products for Human Use has recommended European Commission approval of obecabtagene autoleucel, or obe-cel, for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The CHMP recommendation was based on the results of the FELIX study, an open-label, multi centre, single arm study in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia.
Obe-cel is currently approved by the U.S. Food and Drug Administration, and authorized by the U.K. Medicines and Healthcare products Regulatory Agency.
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