EMA’s CHMP recommends Autolus’ CD19 CAR T

In its May meeting, EMA’s CHMP recommended approval of five new medicines and four label expansions, while issuing a negative opinion to an HDAC inhibitor. 

The agency recommended conditional marketing of CAR T therapy Aucatzyl obecabtagene autoleucel from Autolus Therapeutics plc (NASDAQ:AUTL) for relapsed or refractory patients with B cell precursor acute lymphoblastic leukemia. In the pivotal Phase I/II FELIX trial, the CD19 CAR T therapy led to a median overall survival of 15.6 months, with 6- and 12-month overall survival 80% and 61%, respectively. Complete responses were seen in about 45% of patients. ...