FDA Approves Gamida Cell’s Cell Therapy for Treating Blood Cancers

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Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

FDA announced on April 17, 2023 the approval of Israel-based cell therapy company Gamida Cell’s Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils, a subset of white blood cells, in the body and reduce the risk of infection.

The therapy is intended for use in adults and pediatric patients aged 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, such as radiation or chemotherapy. Gamida Cell will manufacture Omisirge at its good manufacturing practice facility in Kiryat Gat, Israel. The company expects to deliver the cell therapy to transplant centers within 30 days after the start of manufacturing.

Stem cell transplantation is a common treatment for blood cancers. The procedure involves insertion of healthy stem cells in the body to help restore normal production and function of blood cells. Generally, a patient will undergo therapies such as radiation or chemotherapy before this kind of transplant, which may weaken an individual’s immune system. As a result, a frequent and serious risk of this treatment is the occurrence of severe and sometimes deadly infections.


“Today’s approval is an important advance in cell therapy treatment in patients with blood cancers,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an FDA press release. “Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation. This approval reflects [FDA]’s continued commitment to supporting development of innovative therapies for life-threatening cancers.”
Source: FDA and Gamida Cell