January 14th, 2020

// Health Canada Approves Astellas’ XOSPATA® (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

Health Canada Approves Astellas’ XOSPATA® (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

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.

MARKHAM, ON, Jan. 14, 2020 /CNW/ – Astellas Pharma Canada, Inc., announced that Health Canada has approved the oral once-daily therapy XOSPATA (gilteritinib) for the treatment of adult patients with relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation. Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) mutation.1,2 

AML is a cancer of the bone marrow and the blood and progresses rapidly without treatment.3 There are limited options for patients once they have relapsed or are refractory.4

“AML is a life-threatening cancer with an overall five-year survival rate in Canada of only about 20 per cent,” says Dr. Andre Schuh, Hematologist and Clinical Researcher at the Princess Margaret Cancer Centre in Toronto. “Retreatment of relapsed AML is particularly difficult, especially in the presence of a FLT3 mutation. The approval of XOSPATA is one of the few advances in the treatment of AML over the past 40 years and provides a new option for patients with a FLT3 mutation, potentially leading to both disease remission and significantly longer survival.”

AML can be diagnosed at any time, but is uncommon before the age of 45, with the average age of diagnosis being 68.5 In 2016, the most recent year for which data is available, almost 1,090 Canadians were diagnosed with AML, while 1,184 died from AML in 2017. 6 FLT3 mutations are detected in approximately 30% of patients with AML.7 However, a patient’s FLT3 mutation status can change over the course of AML treatment, even after relapse. Due to the poor outcomes associated with FLT3 mutated AML, a patient’s mutation status should be determined to help inform the best treatment approach.8,9,10

“Our mission at Astellas is to put the patients and their families at the centre of everything we do,” said Steve Sabus, General Manager, Astellas Pharma Canada, Inc. “The approval of XOSPATA offers improved treatment outcomes and new hope to patients with FLT3 mutated AML. We’re extremely proud to bring this targeted treatment to Canadian patients.”

About Gilteritinib’s Approval 
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.

References

1 XOSPATA (gilteritinib) Product Monograph, Astellas Pharma Canada, Inc. December 23, 2019. 
2 Perl, A et al. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. New England Journal of Medicine 2019; 381:1728-40.
3 Leukemia & Lymphoma Society of Canada. Acute Myeloid Leukemia. 2019. Available at: https://www.llscanada.org/leukemia/acute-myeloid-leukemia#:~:targetText=Acute%20myeloid%20leukemia%20(AML),carry%20out%20their%20normal%20functions.
4 National Comprehensive Cancer Network. NCCN Guidelines® & Clinical Resources. 2019. Available at: https://www.nccn.org/professionals/physician_gls/categories_of_consensus.aspx
5 Cancer.Net. Doctor-Approved Patient Information from ASCO®. Available at: https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics. Last accessed November 2019.
6 Canadian Cancer Society. Acute myelogenous leukemia. Available at: https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-acute-myelogenous-aml/statistics/?region=on. Last accessed November 2019.
7 NCBI. US National Library of Medicine National Institutes of Health. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6365380/. Last accessed November 2019.
8 Nazha A, et al. Activating internal tandem duplication mutations of the fms-like tyrosine kinase-3 (FLT3-ITD) at complete response and relapse in patients with acute myeloid leukemia. Haematologica 2012;97(8):1242-5.
9 Warren M, et al. Clinical impact of change of FLT3 mutation status in acute myeloid leukemia patients. Mod Pathol 2012;25(10):1405-12.
10 McCormick SR, et al. FLT3 mutations at diagnosis and relapse in acute myeloid leukemia: cytogenetic and pathologic correlations, including cuplike blast morphology. Arch Pathol Lab Med 2010;134(8):1143-51.
11 US Food and Drug Administration. FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627072.htm. Last accessed October 2019.
12 Japan Pharmaceutical and Medical Devices Agency (PMDA). New Drug approvals, April 2018 – March 2019. Available at: http://www.pmda.go.jp/files/000229380.pdf#page=5. Last accessed October 2019.
13 European Commission. European Commission Approves Astellas’ XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation. Available at: https://www.prnewswire.com/news-releases/european-commission-approves-astellas-xospata-gilteritinib-as-a-monotherapy-for-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-with-a-flt3-mutation-300945407.html

SOURCE Astellas Pharma Canada, Inc.

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