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FDA Approves Autolus’s CAR-T Therapy Aucatzyl for Relapsed or Refractory B-ALL in Adults

NextEdge Admin

12 Nov 2024

2 min 10 sec

Autolus Therapeutics has received FDA approval for Aucatzyl (obecaktagene autoleucel), its CAR-T cell therapy for adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukemia (B-ALL). This approval comes amid heightened regulatory scrutiny on CAR-T therapies, with the FDA issuing new boxed warnings in April due to rare cases of T cell malignancies. Aucatzyl’s label includes warnings for cytokine release syndrome (CRS) and neurologic toxicities, common risks in CAR-T treatments.

The decision was based on the FELIX trial, which studied Aucatzyl in adults with relapsed or refractory B-ALL. Among a subgroup of 65 patients with over 5% bone marrow blasts, the therapy showed a 63% complete remission rate, with 42% achieving remission within three months. The median remission duration was 14.1 months. Severe adverse events were limited, with 3% experiencing Grade 3 CRS and 7% facing Grade 2 or 3 neurotoxicity (ICANS). No Grade 4 or 5 CRS events were reported.

The FDA opted not to impose a risk evaluation and mitigation strategy (REMS) for Aucatzyl, consistent with recent moves to ease REMS requirements for similar therapies. This approval positions Aucatzyl in a competitive market, joining Gilead’s Tecartus, which was approved in 2021 for B-ALL. Autolus has not yet set Aucatzyl’s list price, and applications for market authorization are under review in the UK and EU.