Omidubicel PDUFA Date Extended to May 2023


Omidubicel’s BLA was originally accepted for priority review in August of this year.

The Prescription Drug User Fee Act (PDUFA) date for Gamida Cell’s omidubicel, an investigational allogeneic hematopoietic stem cell transplant (HSCT) candidate intended for the treatment of patients with hematological cancers, has been extended from its original January 30, 2023, date to May 1, 2023.1

The extension comes more than 3 months after the company originally announced the acceptance for filing with priority review of omidubicel’s biologics license application (BLA) by the FDA in August 2022.2 The extension is related to laboratory data for intermediate time points from patients participating in the phase 3 clinical trial (NCT0273029) that Gamida Cell gave in response to a request for information issued by the FDA, which the agency considered a major amendment.1 The company noted that these laboratory results are consistent with data included in previous submissions. Gamida Cell’s late-cycle meeting with the FDA has additionally been rescheduled to the first quarter of next year.

“We appreciate the FDA’s collaboration as they conduct their review of omidubicel,” Abigail “Abbey” Jenkins, president and chief executive officer, Gamida Cell, said in a statement regarding the news.1 “If approved, omidubicel will be the first and only advanced cell therapy for patients with blood cancer in need of an allogeneic stem cell transplant. We are committed to bringing this potentially transformative therapy forward as quickly as possible.”

Omidubicel has previously been granted breakthrough therapy designation by the FDA and orphan drug designation by both the FDA and the European Medicines Agency.3 The investigational product consists of umbilical cord blood–derived cells modified with the company’s nicotinamide (NAM) technology which is intended to increase the amount and potency of the cells.1,3

Data from omidubicel’s phase 3 trial showing an improvement in survival for patients with hematological malignancies receiving allogeneic HSCT were recently presented at the 10th Annual Meeting of the Society of Hematologic Oncology (SOHO), which took place September 28-October 1 in Houston, Texas.4 Participants included in the analysis achieved an overall survival rate of 63% (95% CI, 53%-73%) and a disease-free survival rate of 56% (95% CI, 47%-67%) at a median follow-up of 22 months (range, 0.3-122.5) overall and 35.7 months (range, 11.7-122.5) for survivors.

1. Gamida Cell provides regulatory update on omidubicel. News release. Gamida Cell Ltd. November 21, 2022. 
2. Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review. News release. Gamida Cell Ltd. August 1, 2022. 
3. Gamida Cell. Our R&D. Website. Accessed November 22, 2022. 
4. Lin C, Schwarzbach A, Montesinos P, et al. Multicenter long-term follow-up of allogeneic hematopoietic cell transplantation with omidubicel: A pooled analysis of five prospective clinical trials. Presented at: 10th Annual Meeting of the SOHO, September 28- October 1, Houston, Texas.
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