EU Approves Obe-cel for Relapsed or Refractory B-ALL

The European Commission has approved obecabtagene autoleucel (obe-cel), a second-generation anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). Autolus Therapeutics, the manufacturer, announced the authorization on Monday.

Obe-cel, marketed as Aucatzyl, received approval based on results from the FELIX trial, which reported a 77% overall remission rate (55% complete remission and 21% complete remission with incomplete hematologic recovery). The median event-free survival (EFS) was 11.9 months, with estimated EFS rates at six and 12 months of 65.4% and 49.5%, respectively.

Obe-cel was previously approved by the U.S. Food and Drug Administration and authorization from the U.K. Medicines and Healthcare products Regulatory Agency.