Gamida Cell-Teva Joint Venture's StemEx program receives FDA Fast Track Designation

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma.

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products).

The letter sent by the Department of Health and Human Services to the Gamida Cell-Teva Joint Venture stated: your request meets the criteria for the Fast Track designation. Therefore, we are designating as a Fast Track development program the investigation of StemEx (ex vivo expanded cord blood) as a supportive treatment to enhance hematopoietic re-constitution of umbilical cord blood cell transplant to improve 100-day post-transplant mortality in adults and adolescents who receive myeloablative therapy for high risk hematological malignancies.

SOURCE Gamida Cell


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