Autolus submits BLA to FDA for cell therapy obe-cel in r/r adult B-ALL

Autolus Therapeutics plc

BLA for obecabtagene autoleucel (obe-cel) submitted to FDA for relapsed/refractory adult B-cell ALL.
Submission based on Phase 2 FELIX study data presented at ASCO 2023; updated data at ASH December 2023.
Autolus on track to submit Marketing Authorization Application to EMA in H1 2024.
Obe-cel has FDA Orphan Drug, RMAT, and EMA PRIME designations.

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