FDA approves Autolus' AUCATZYL (obe-cel) for adult r/r B-ALL; no REMS required

Autolus Therapeutics plc

Approval based on FELIX trial: 63% overall complete remission (CR/CRi) in efficacy-evaluable patients (n=65); median DOR 14.1 months.
Only 3% Grade ≥3 CRS and 7% Grade ≥3 ICANS; no REMS program required by FDA.
Boxed warning for CRS, neurologic toxicities, secondary hematological malignancies; T-cell malignancies risk noted.
Commercial manufacturing at Nucleus in Stevenage, UK; Cardinal Health as U.S. distribution partner.
EU and UK MAAs under review; company to host conference call Nov 11.

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