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Gilteritinib Approval Status

FDA Approved: No (Pending Approval)
Generic name: gilteritinib
Company: Astellas Pharma US, Inc.
Treatment for: Acute Myeloid Leukemia

Gilteritinib is an inhibitor of the tyrosine kinases FLT3/AXL in development for the treatment of patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML).

Development Status and FDA Approval Process for gilteritinib

DateArticle
May 29, 2018U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Apr 23, 2018Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia
Dec 11, 2017Astellas Announces First Clinical Data from Phase I Study of Gilteritinib in Combination with Intensive Chemotherapy in Patients Newly Diagnosed with Acute Myeloid Leukemia
Oct 10, 2017FDA Grants Fast Track Designation to Astellas for Development of Gilteritinib in Relapsed or Refractory Acute Myeloid Leukemia
Aug 21, 2017First Patient Dosed in Phase 3 MORPHO Trial Evaluating Gilteritinib as Maintenance Therapy Following Hematopoietic Stem Cell Transplant in Patients with FLT3 Mutation-positive Acute Myeloid Leukemia
Jul 20, 2017U.S. FDA Grants Orphan-Drug Designation to Astellas for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia
Oct 28, 2015Astellas Inititaties Phase 3 Registration Trial of gilteritinib (ASP2215) in Relapsed or Refractory Acute Myeloid Leukemia Patients

Further information

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