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.