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# Priority Review for Gamida’s Omidubicel
- URL: https://www.fdaweb.com/priority-review-for-gamidas-omidubicel/
- Published: 2022-08-02T12:00:00.000Z
- Updated: 2026-09-14T17:54:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152428

FDA has accepted for priority review a Gamida Cell BLA for omidubicel for treating patients with blood cancers in need of an allogenic hematopoietic stem cell transplant. Omidubicel is described as a first-in-class, advanced NAM-enabled stem cell therapy candidate. The agency has set a user fee review action target date of 1/30/2023.

The BLA is based on data from the company’s pivotal Phase 3 study, which evaluated the primary endpoint of median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant with omidubicel compared to standard umbilical cord blood. Data demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to omidubicel compared to 22 days for the comparator group, the company says.