FDA Delays Decision Date on Gamida Cell BLA
The FDA has pushed back its decision date for Gamida Cell’s Biologics License Application (BLA) for omidubicel — a drug that treats patients with blood cancer in need of a bone marrow transplant — by three months.
The delay follows the agency’s request for laboratory results for intermediate time points in a phase 3 study. The FDA viewed the company’s response as a major amendment resulting in an extension of the decision date from Jan. 30 to May 1, 2023.
Omidubicel showed a statistically significant reduction in time to begin blood cell healing when compared to standard umbilical cord blood in an international phase 3 study of patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The study also showed reduced infections and fewer days of hospitalization in participants who received the drug.
About Omidubicel
Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies.
November 29, 2022
