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# FDA Accepts Autolus Obe-Cel BLA
- URL: https://www.fdaweb.com/fda-accepts-autolus-obe-cel-bla/
- Published: 2024-01-23T12:00:00.000Z
- Updated: 2026-09-14T14:20:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156194

FDA has accepted for review an Autolus Therapeutics BLA for obecabtagene autoleucel (obe-cel) as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukemia. A company [statement](https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-announces-acceptance-biologics-license?ref=fdaweb.com) says FDA has set a PDUFA target action date of 11/16.

The submission is based on data from the pivotal Phase 2 FELIX study of obe-cel in relapsed/refractory adult B-cell acute lymphoblastic leukemia. The drug has been granted FDA orphan drug designation and regenerative medicine advanced therapy.

Obe-cel is described as a CD19 CAR T-cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T-cell therapies. It is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells.