Autolus Therapeutics announces FDA acceptance of BLA for obe-cel; PDUFA date Nov 16, 2024

Autolus Therapeutics plc

FDA accepted BLA for obe-cel in relapsed/refractory Adult B-ALL; PDUFA target action date November 16, 2024.
No advisory committee meeting is currently planned for this application.
BLA submission based on Phase 2 FELIX study data presented at ASCO 2023 and ASH 2023.
Company plans to submit Marketing Authorization Application to EMA in H1 2024.
Obe-cel has Orphan Drug, RMAT (FDA), and PRIME (EMA) designations.

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