Gamida Cell’s Omisirge receives FDA approval

pharmafile | April 18, 2023 | News story | Research and Development  

Cell therapy pioneer Gamida Cell has announced FDA approval of its allogeneic cell therapy, Omisirge (omidubicel-onlv), for use in adult patients and paediatric patients over the age of 12.

The drug is intended to treat patients with haematologic malignancies planned for treatment with umbilical cord transplants and myeloblative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Omisirge has received Breakthrough Therapy Designation, Priority Review and Orphan Drug Designation from the FDA, and is the first allogeneic stem cell transplant therapy to be approved following a global randomised phase 3 clinical study.

The phase 3 clinical study for Omisirge demonstrated a median time to neutrophil recovery of 12 days compared to 22 days for the standard cord blood transplant. The safety profile for the drug remains consistent with what was expected, with some adverse events being reported, such as infusion reactions in 47% of patients, acute graft-versus-host-disease (GvHD) in 58%, chronic GvHD in 35% and graft failure in 3%. Full results of the study can be found in Blood.

Abbey Jenkins, president and CEO at Gamida Cell, commented: “FDA approval of Omisirge is a major advancement in the treatment of patients with haematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes. We are grateful to all the clinicians, patients and the entire Gamida Cell team without whom this approval would not have been possible. We also acknowledge the key role the FDA has played in supporting the development of Omisirge and other innovative and potentially life-saving cell therapies for patients with cancer and other serious diseases.”

Steven M Devine, MD, chief medical officer at the National Marrow Donor Program (NMDP)/Be The Match, added: “The approval of Omisirge is a significant development in haematopoietic stem cell transplantation. Patients who are Black or African American have just a 29% chance of finding a match via the donor registry vs a 79% chance for patients who are White. Adding Omisirge as a new donor source may help increase access to stem cell transplant for patients from racially or ethnically diverse backgrounds who struggle to find a fully matched donor in the registry.”


Betsy Goodfellow

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