PTx gains global rights to sargramostim from Sanofi

Partner Therapeutics (PTx) acquires the global rights to develop, manufacture, and commercialize sargramostim (Leukine, Sanofi). Sargramostim is the only Food and Drug Administration (FDA)-approved recombinant human granulocyte-macrophage colony stimulating factor. PTx will support the development of sargramostim for new indications; it is currently being tested in a phase III trial in frontline melanoma in combination with ipilimumab and nivolumab, as well as in the treatment of hematopoietic syndrome of acute radiation syndrome (H-ARS). A supplemental Biologics License Application was filed in September of 2017 with the FDA requesting approval of sargramostim for the treatment of H-ARS. In December, the application was granted Priority Review with a Prescription Drug User Fee Act date of March 29, 2018.

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