• Completion of pan-Canadian Pharmaceutical Alliance (pCPA) negotiations enables public reimbursement of Vanflyta across Canada, with Quebec reimbursing Vanflyta in May 2026
• Reimbursement includes use across induction, consolidation and maintenance phases of treatment 

TORONTO , May 28, 2026 /CNW/ - Vanflyta^® (quizartinib) is now publicly reimbursed in Canada in Quebec, enabling access for adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) across induction, consolidation and maintenance phases of treatment (with or without transplant).¹ This follows the execution of a Letter of Intent with the pCPA and after Vanflyta received its Notice of Compliance from Health Canada in June 2025.

Vanflyta is a FLT3 inhibitor being developed and commercialized by Daiichi Sankyo (TSE: 4568) for the treatment of patients with newly-diagnosed FLT3-ITD positive AML, with approximately 25% of all new AML cases being FLT3-ITD positive.^1,2,3 A validated test is required to confirm the FLT3-ITD status of AML.¹

The approval of Vanflyta by Health Canada was based on the results of the QuANTUM-First phase 3 trial, which were published in The Lancet.¹² In QuANTUM-First, Vanflyta combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation and continued as maintenance monotherapy following consolidation, demonstrated a 22.4% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; 2-sided p=0.0324]) in patients with newly diagnosed FLT3-ITD positive AML.^1,  Median overall survival (OS) was 31.9 months for patients receiving Vanflyta (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.¹²

"Patients with FLT3-ITD positive AML continue to face a high risk of relapse, particularly in the maintenance setting where treatment options have been limited," said Fatih Yedikardeş, Country Manager Canada, Daiichi Sankyo. "The reimbursement of Vanflyta across all phases of treatment, including maintenance, marks an important step forward in addressing this unmet need and improving outcomes for patients in Canada."

AML is one of the most common forms of acute leukemia in adults, representing approximately 80% of all cases.^3,4 FLT3 gene mutations occur in approximately 30% of newly diagnosed patients with AML.³  Approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to an increased risk of relapse and shorter overall survival.^3,4,7 The five-year survival rate for adult patients with AML receiving the current standard of care has been reported at approximately 26%.⁵

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating Vanflyta in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant, and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive Vanflyta or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance.

The primary study endpoint was OS. Secondary endpoints include event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR, were also evaluated. 

QuANTUM-First enrolled 539 patients in Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About FLT3 -ITD Positive Acute Myeloid Leukemia

A number of gene mutations have been identified in AML, and FLT3 (FMS-like tyrosine kinase) mutations are the most common.⁶ Approximately 80% of these FLT3 cases are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.^3,7 Approximately 487,000 new cases of leukemia were diagnosed globally in 2022 with more than 305,000 deaths.⁸  AML accounts for approximately 23,1% of total leukemia cases worldwide and is most common in adults.^9,10 In Canada, approximately 1,300 people died from AML in 2022 and it remains the second most commonly diagnosed blood cancer.¹¹ 

About Vanflyta

Vanflyta is an oral, highly potent and selective type II FLT3 inhibitor approved in more than 30 countries. In Canada, Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta maintenance monotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive. Improvement in overall survival has not been demonstrated for maintenance monotherapy following allogeneic hematopoietic stem cell transplantation. A validated test is required to confirm the FLT3-ITD status of AML.¹ 

About Daiichi Sankyo

Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit http://www.daiichisankyo.com.

REFERENCES

¹ Current Vanflyta Product Monograph. Daiichi Sankyo Pharma Canada Ltd.
² Vakiti A, et al. Stat Pearls. Updated April 2024.
³ Daver N, et al. Leukemia. 2019;33(2):299-312.
⁴ Patel JP, et al. N Engl J Med. 2012;14;366(12):1079–1089.
⁵ Canadian Cancer Society. Survival statistics for acute myeloid leukemia. Accessed March 2025.
⁶ Kennedy VE, et al. Front Onc. 23 December 2020;10. Volume 10 – 2020. 
⁷ Gordon J, et al. Blood Cancer J. (2024) 14:125. 
⁸ Global Cancer Observatory. Leukaemia. Accessed March 2025.
⁹ American Cancer Society: Key Statistics for Acute Myeloid Leukemia. Updated January 2023.
¹⁰ Dong Y, et al. Exp Hematol Oncol. (2020);9:14.
¹¹ Canadian Cancer Society. Acute myeloid leukemia statistics. Accessed March 2025.
¹² Erba HP, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. (2023) 401(10388):1571-1583.

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SOURCE Daiichi Sankyo