Health Canada Approves Astellas' XOSPATA (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Health?Canada's?approval of gilteritinib is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3 mutated AML. Patients treated with gilteritinib had significantly longer overall survival (OS) than those who received salvage chemotherapy. Median OS for patients who received gilteritinib was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83), P=0.0004). Rates of one-year survival were 37% for patients who received gilteritinib, compared to 17% for patients who received salvage chemotherapy.?1,2 About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib was approved in the U.S. and?Japan?in 2018, and?Europe?in 2019, for the treatment of adult patients who have relapsed or refractory FLT3 mutated AML.?11,12,13 About the ADMIRAL Trial
The Phase 3 ADMIRAL trial was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutation 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, the primary endpoint at the trial's final analysis, was the basis of the Health Canada's approval. The study enrolled 371 patients with relapsed or refractory AML and FLT3 mutation present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.1,2 The most frequent adverse reactions (=10%) with Xospata were aspartate aminotransferase (AST) increased (37.6%), alanine aminotransferase (ALT) increased (37.6%), diarrhea (35.1%), fatigue (30.4%), nausea (29.8%), cough (28.2%), constipation (28.2%), peripheral edema (24.1%), dyspnea (24.1%), headache (23.5%), vomiting (21.0%), blood alkaline phosphatase increased (20.7%), dizziness (20.4%), hypotension (17.2%), decreased appetite (17.2%), rash (15.0%), stomatitis (13.5%), abdominal pain (13.2%), dysgeusia (11.0%).1 About Astellas Pharma Canada, Inc.?
Astellas Pharma Canada, Inc., headquartered in?Markham, ON, is a Canadian affiliate of?Tokyo-based Astellas Pharma Inc. In?Canada, Astellas has an intense commercial focus on three therapeutic areas ? Oncology, Immunology and Urology. For more information about Astellas Pharma Canada, Inc., please visit astellas.com/ca. Dr. Schuh was not compensated for any media work.? He has been a paid consultant to Astellas Pharma Canada, Inc.
XOSPATA is the first and only targeted treatment approved by Health Canada for patients with relapsed or refractory Acute Myeloid Leukemia with a FLT3 mutation.?
The?approval of XOSPATA marks Astellas' Canadian entry into the treatment of blood cancers.
Health?Canada's?approval of gilteritinib is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3 mutated AML. Patients treated with gilteritinib had significantly longer overall survival (OS) than those who received salvage chemotherapy. Median OS for patients who received gilteritinib was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83), P=0.0004). Rates of one-year survival were 37% for patients who received gilteritinib, compared to 17% for patients who received salvage chemotherapy.?1,2 About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib was approved in the U.S. and?Japan?in 2018, and?Europe?in 2019, for the treatment of adult patients who have relapsed or refractory FLT3 mutated AML.?11,12,13 About the ADMIRAL Trial
The Phase 3 ADMIRAL trial was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutation 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, the primary endpoint at the trial's final analysis, was the basis of the Health Canada's approval. The study enrolled 371 patients with relapsed or refractory AML and FLT3 mutation present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.1,2 The most frequent adverse reactions (=10%) with Xospata were aspartate aminotransferase (AST) increased (37.6%), alanine aminotransferase (ALT) increased (37.6%), diarrhea (35.1%), fatigue (30.4%), nausea (29.8%), cough (28.2%), constipation (28.2%), peripheral edema (24.1%), dyspnea (24.1%), headache (23.5%), vomiting (21.0%), blood alkaline phosphatase increased (20.7%), dizziness (20.4%), hypotension (17.2%), decreased appetite (17.2%), rash (15.0%), stomatitis (13.5%), abdominal pain (13.2%), dysgeusia (11.0%).1 About Astellas Pharma Canada, Inc.?
Astellas Pharma Canada, Inc., headquartered in?Markham, ON, is a Canadian affiliate of?Tokyo-based Astellas Pharma Inc. In?Canada, Astellas has an intense commercial focus on three therapeutic areas ? Oncology, Immunology and Urology. For more information about Astellas Pharma Canada, Inc., please visit astellas.com/ca. Dr. Schuh was not compensated for any media work.? He has been a paid consultant to Astellas Pharma Canada, Inc.