Autolus Therapeutics (AUTL) said Friday that its obecabtagene autoleucel therapy has been recommended for European Commission approval by the European Medicines Agency's Committee for Medicinal Products for Human Use for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The commission is expected to make a decision on the conditional marketing authorization application for the therapy within two months, with the decision applying to all EU member states, Iceland, Norway, and Liechtenstein, the company said.