Gilteritinib has been approved under an expedited pathway, following NMPA's acceptance of gilteritinib for priority review in
'Patients with relapsed or refractory AML with a FLT3 mutation are in urgent need of new treatment options,' said Professor
Gilteritinib has shown itself to be effective against two types of FLT3 mutation - FLT3 internal tandem duplication (FLT3-ITD) and FLT3 tyrosine kinase domain (FLT3-TKD). Impacting approximately 30% of AML patients,3 the FLT3-ITD mutation is associated with higher risk of relapse and shorter overall survival compared to wild-type FLT3.4,5 FLT3-TKD mutations impact approximately 7% of AML patients.3 The status of FLT3 mutation can change over the course of AML treatment, including after relapse. Confirming patients' FLT3 mutation status at the time of relapse can help inform an appropriate and potentially targeted treatment approach.6
'Having a FLT3 mutation has a highly negative impact on prognosis for people living with AML,' said Professor
AML is a cancer that impacts the blood and bone marrow,7 and its incidence increases with age.8 It is one of the most common types of leukemia in adults.9 Every year, it is estimated that around 80,000 people in
'There is an urgent unmet need among FLT3-mutated relapsed or refractory AML patients, whose median survival is currently less than six months with chemotherapy,' said
The approval was based on results from the Phase 3 ADMIRAL trial, published in the
The safety of gilteritinib was evaluated in 319 patients with relapsed or refractory AML who have received at least one dose of 120 mg gilteritinib daily.11 The most frequent all-grade adverse reactions (frequency 10%) with gilteritinib were alanine aminotransferase (ALT) increased (25.4%), aspartate aminotransferase (AST) increased (24.5%), anemia (20.1%), thrombocytopenia (13.5%), febrile neutropenia (12.5%), platelet count decreased (12.2%), diarrhea (12.2%), nausea (11.3%), blood alkaline phosphatase increased (11%), fatigue (10.3%), white blood cell count decreased (10%), and blood creatine phosphokinase increased (10%). One fatal adverse reaction of differentiation syndrome occurred in patients receiving gilteritinib. The most frequent (frequency 3%) serious adverse reactions were febrile neutropenia (7.5%), ALT increased (3.4%), and AST increased (3.1%). Other clinically significant serious adverse reactions included electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.3%).
Astellas has already reflected the impact from this approval in its financial forecast of the current fiscal year ending
About the ADMIRAL Trial
The Phase 3 ADMIRAL trial (NCT02421939) was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3mut+ who are refractory to or have relapsed after first-line AML therapy. The co-primary endpoints of the trial were OS and CR/CRh rates; OS was the primary endpoint at the trial's final analysis. The study enrolled 371 patients with relapsed or refractory AML and FLT3mut+ present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.
About the COMMODORE Trial
The Phase 3 COMMODORE trial (NCT03182244) is an open-label, multicenter, randomized ongoing study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in
About Gilteritinib
Gilteritinib was discovered through a research collaboration with
About Astellas
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Contact:
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Email: chris.goldrick@astellas.com
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