ALPMF - Astellas' Xospata meets overall survival endpoint in late-stage blood cancer study

Astellas Pharma (ALPMF) announces that a Phase 3 confirmatory trial of Xospata (gilteritinib) in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia ((AML)) met its primary endpoint of overall survival ((OS)) compared to chemotherapy at a planned interim analysis. Astellas has stopped enrollment in the trial and patients in the chemotherapy arm will be offered the opportunity to receive gilteritinib. Earlier this year, China granted conditional approval to gilteritinib for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation. Astellas plans to submit results of COMMODORE trial to the NMPA in support of full approval. "In COMMODORE, patients receiving gilteritinib lived longer than those receiving salvage chemotherapy, confirming the overall survival benefit seen in the Phase 3 ADMIRAL trial," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development.

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Astellas' Xospata meets overall survival endpoint in late-stage blood cancer study