First Allogeneic Stem Cell Transplant Therapy Approved by the FDA
19 April 2023
Cell therapy pioneer Gamida Cell has announced the FDA has approved its allogeneic cell therapy Omisirge, as a source of stem cell transplant for patients with hematological malignancies.
As the first allogenic stem cell transplant therapy to be approved, Omisirge takes cells from a donor and will be used to treat adults and pediatric patients over 12 years old with hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid malignancies, and myelodysplastic syndromes, planned for umbilical cord blood transfusions following myeloablative conditioning.
Manufactured in Gamida’s state-of-the-art GMP manufacturing facility in Israel, Omisirge works to enhance and expand the number of progenitor cells utilizing proprietary nicotinamide technology in order to preserve their stemness, homing to bone marrow and retained engraftment capacity and is delivered to patients in transplant centers within 30 days.
“FDA approval of Omisirge is a major advancement in the treatment of patients with hematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes,” said Abbey Jenkins, President and CEO of Gamida Cell.
The FDA approval was based on the results of Gamida’s global, randomized Phase III clinical trial in which Omisirge demonstrated faster neutrophil recovery and reduced bacterial and fungal infection in the treated patients, compared with standard cord blood transplants.
Gamida shared in the official journal of the American Society of Hematology, that Omisirge had a median time to neutrophil recovery of 12 days – 10 days quicker than the 22 days of standard cord blood.
The safety profile reported from the Phase III trial was consistent with the expected adverse events of allogeneic hematopoietic stem cell transplants following myeloablative conditioning.
Patients can now access this treatment in U.S. transplant centers, with Omisirge set to help address health disparities in stem cell transplants.
“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.3 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,” said Steven M. Devine, M.D., Chief Medical Officer at the National Marrow Donor Program® (NMDP)/Be The Match®.
Following the recent collaboration with strategic advisor Moelis & Company, Gamida continues to pursue strategic partnerships in order to support the launch and commercialization of Omisirge across the U.S and the rest of the world.
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