Having access to an additional treatment option offers hope for Canadian adult AML patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.

MARKHAM, ON, April 21, 2022 /CNW/ - Astellas Pharma Canada, Inc., announces today on World AML Day, that Alberta1, British Columbia2, Manitoba3, New Brunswick4, Newfoundland and Labrador5, Nova Scotia6, Ontario7, Quebec8, Saskatchewan9, and the Non-Insured Health Benefits (NIHB) program10 have all reimbursed XOSPATA® (gilteritinib), an oral once-daily therapy, 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 as confirmed by a validated test. 

AML is a cancer of the bone marrow that can progress rapidly without treatment.11 AML is the most common acute leukemia in adults,12  and FLT3 mutations are detected in approximately 30 per cent of those with AML.13 XOSPATA 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.14,15 There are many different types of mutations in AML, and FLT3 mutations are the most common.16 
Astellas received Health Canada approval for XOSPATA in December 2019. This marked Astellas’ first Canadian entry into the treatment of blood cancers and an expansion of their oncology portfolio. 

“AML is a terrible disease, often with devastating outcomes. We take our responsibility to Canadians with AML seriously as we work to make important medicines available to those who need them most,” says Frank Stramaglia, General Manager, Astellas Pharma Canada, Inc. “There is a high unmet need for FLT3-positive relapse or refractory AML treatments, and we are proud that the reimbursement of XOSPATA means eligible Canadians now have access to this targeted therapy.”

Astellas is committed to continuing to work with governments, payers, advocacy groups, healthcare providers and patients to support access for any adult with relapsed or refractory FLT3-mutated AML who may benefit from XOSPATA. 

Health Canada’s approval of XOSPATA (gilteritinib) was 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 = 0.637 (95 per cent CI 0.490, 0.830), P=0.0004). Rates of one-year survival were 37 per cent for patients who received gilteritinib, compared to 17 per cent for patients who received salvage chemotherapy.

About Astellas Pharma Canada, Inc. 
Astellas Pharma Canada, Inc. is a Canadian affiliate of Tokyo-based Astellas Pharma Inc., a pharmaceutical company conducting business in more than 70 countries around the world. Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people in Canada and around the world. 



1 Alberta Health Services Outpatient Cancer Drug Benefit Program. March 25, 2022. Available at: https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf (accessed April 13, 2022).
2 British Columbia Cancer Benefit Drug List. April 2022. Available at: http://www.bccancer.bc.ca/systemic-therapy-site/Documents/Policy%20and%20Forms/Benefit%20Drug%20List.pdf (accessed April 13, 2022).
3 Manitoba Drug Benefits and Interchangeability Formulary Amendments. August 5, 2021. Available at: https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin112.pdf (accessed April 13, 2022). 
4 New Brunswick Drug Plans Formulary. April 2022. Available at: https://www2.gnb.ca/content/dam/gnb/Departments/h-s/pdf/en/NBDrugPlan/NewBrunswickDrugPlansFormulary.pdf  (accessed April 13, 2022).
 5 Newfoundland and Labrador Prescription Drug Program Drug Product Database. December 2021. Available at: https://www.health.gov.nl.ca/health/prescription/class_search_nl.asp?din=02495058&GReturn=GenericName&Subtitle1=Generic%20or%20Brand%20Name%20:%20%20%20&Subtitle2=xospata (accessed April 13, 2022).
6 Nova Scotia Formulary. April 2022. Available at: https://novascotia.ca/dhw/pharmacare/documents/formulary.pdf  (accessed April 13, 2022).  
7 Ontario Exceptional Access Program Reimbursement Criteria for Frequently Requested Drugs. January 1, 2022. Available at: https://health.gov.on.ca/en/pro/programs/drugs/docs/frequently_requested_drugs.pdf (accessed April 13, 2022). 
8 Régie de l’assurance maladie du Québec. List of Medications (RAMQ: Official Mark of the Régie de l’assurance maladie du Québec.) December 15, 2021. Available at: https://www.ramq.gouv.qc.ca/sites/default/files/documents/liste_med_2021-12-15_en.pdf (accessed April 13, 2022).
9 Saskatchewan Cancer Agency Drug Formulary. April 1, 2022. Available at: http://www.saskcancer.ca/images/pdfs/health_professionals/drug_formulary/drug_formulary/SCA_Drug_Formulary_-_2022-04-01.pdf (accessed April 13, 2022).
10 Government of Canada. Non-Insured Health Benefits program updates. Available at: https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407. Accessed April 13, 2022. 
11 Leukemia & Lymphoma Society of Canada. Acute Myeloid Leukemia. 2021. Available at: https://www.bloodcancers.ca/sites/default/files/2021-08/LLS1083-F-FS-AML-8P-E05.pdf. Accessed April 13, 2022.
12 Leukemia & Lymphoma Society of Canada. Acute Myeloid Leukemia. 2021. Available at: https://www.bloodcancers.ca/sites/default/files/2021-08/LLS1083-F-FS-AML-8P-E05.pdf. Accessed April 13, 2022.
13  NCBI. US National Library of Medicine National Institutes of Health. Targeting FLT3 mutations in AML: review of current knowledge and evidence. 2019. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6365380/. Accessed April 13, 2022.
14  XOSPATA (gilteritinib) Product Monograph, Astellas Pharma Canada, Inc. January 4, 2022. 
15 Perl, A et al. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. New England Journal of Medicine 2019; 381:1728-40. Accessed April 13, 2022.
16 Xospata: Testing for FLT3 Mutations. https://xospata.com/acute-myeloid-leukemia/flt3-mutation-testing. Accessed April 13, 2022.
17 XOSPATA (gilteritinib) Product Monograph, Astellas Pharma Canada, Inc. January 4, 2022. Accessed April 13, 2022.