Gilteritinib fumarate is under clinical development by Astellas Pharma and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Gilteritinib fumarate’s likelihood of approval (LoA) and phase transition for Myelodysplastic Syndrome took place on 05 Aug 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Gilteritinib fumarate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Gilteritinib fumarate overview

Gilteritinib fumarate (Xospata) is a pyrazine carboxamide derivative, acts as an anti-neoplastic agent. It is formulated as film coated tablets for oral route of administration. Xospata is indicated for the treatment of  FLT3 mutation-positive refractory and relapsed acute myeloid leukemia in adults.

Gilteritinib fumarate (ASP-2215) is under development for the treatment of relapsed or refractory acute myeloid leukemia, post-chemo maintenance acute myeloid leukemia, post-HSCT maintenance acute myeloid leukemia, newly diagnosed acute myeloid leukemia with high intensity induction of chemotherapy and newly diagnosed acute myeloid leukemia with low intensity induction of chemotherapy. It was also under developement for newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy.

Astellas Pharma overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

Quick View Gilteritinib fumarate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Gilteritinib fumarate
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.