UK-based cell therapy company Autolus Therapeutics has received FDA approval for its Biologics License Application (BLA) for the drug obecabtagene autoleucel (obe-cel), a CAR T therapy targeted at patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (r/r B-ALL). The FDA is expected to decide on the application by November 2024.

The company's lead therapeutic candidate, obe-cel, has also received Orphan Drug Designation and Regenerative Medicine Advanced Therapy designation (RMAT) from the FDA and Orphan Medical Product Designation and PRIority MEdicines (PRIME) designation by the European Medicines Agencies (EMA) for adult r/r B-ALL.

Autolus Therapeutics develops programmed T-cell therapies for the treatment of hematological cancers and solid tumors. Obe-cel is used for ALL, and the company is also investigating it for the treatment of B-cell non-Hodgkin lymphoma (B-NHL) indications and pediatric ALL.