• After ENHERTU^®, VANFLYTA^® is the second innovative medicine from the Daiichi Sankyo oncology pipeline to be available in Canada
• Approval based on QuANTUM-First results demonstrating VANFLYTA added to chemotherapy improved overall survival

TORONTO , June 16, 2025 /CNW/ - Daiichi Sankyo's (TSE: 4568) VANFLYTA (quizartinib) has been approved by Health Canada for use 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.¹

Improvement in overall survival (OS) has not been demonstrated for maintenance monotherapy following allogeneic hematopoietic stem cell transplantation.¹

A validated test is required to confirm the FLT3-ITD status of AML.¹

AML is one of the most common forms of leukemia in adults, representing approximately 80% of all cases.²FLT3 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.^3,4FLT3-ITD mutations occur in roughly 25% of all AML cases, with some studies reporting a frequency as high as 30%.^3,4 The five-year survival rate for Canadian patients with AML receiving the current standard of care has been reported at approximately 23%.⁵

VANFLYTA is a novel selective FLT3-ITD inhibitor that when used in combination with standard chemotherapy and across all three phases of treatment: induction, consolidation and maintenance, provides proven survival outcomes in newly diagnosed FLT3-ITD positive AML - even in a population of adults up to 75 years of age.⁶

The approval of VANFLYTA by Health Canada was based on the results of the QuANTUM-First phase 3 clinical trial. 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.^1,6 Median 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.⁶

"The approval of VANFLYTA in Canada represents a significant advancement for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which is one of the most aggressive and difficult-to-treat subtypes," said Brian Leber, MD, FRCP, Professor of Medicine, Department of Medicine, McMaster University. "In the QuANTUM-First trial, VANFLYTA added to standard chemotherapy and continued as maintenance resulted in longer remission and prolonged overall survival and it will be a much needed new treatment option that has potential to change the way FLT3-ITD positive AML is treated."

QuANTUM-First evaluated the safety profile in 265 patients with newly diagnosed FLT3-ITD positive AML treated with VANFLYTA. The most common grade 3 or 4 adverse reactions (incidence ≥ 5%) were febrile neutropenia, sepsis, neutropenia, thrombocytopenia, fungal infections and anemia.^1,6 Cardiac events, such as QT prolongation and rare ventricular arrhythmias, also were observed.⁶

"Despite recent advances in AML treatment, patients with AML bearing FLT3-ITD mutations still face a challenging prognosis," said Andre Schuh, MD, FRCPC, Clinician Investigator, Cancer Clinical Research Unit, Princess Margaret Cancer Centre. "The approval of VANFLYTA offers a promising step forward, bringing hope for better outcomes in this high-risk patient population. Results from the QuANTUM-First trial demonstrated that combining VANFLYTA with standard chemotherapy and continuing it as maintenance therapy, led to deeper, more durable remissions and improved overall survival. As a new option for newly diagnosed FLT3-ITD positive AML, VANFLYTA has the potential to redefine how this aggressive disease is treated in Canada."

"The approval of VANFLYTA in Canada enables patients diagnosed with FLT3-ITD-positive acute myeloid leukemia to receive a targeted therapy specifically developed for their disease subtype," said Fatih Yedikardeş, Country Manager Canada, Daiichi Sankyo. "This milestone reflects our commitment to transforming cancer therapy, advancing innovation in hematology and oncology and creating new standards of care for patients."

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating VANFLYTA versus standard chemotherapy on overall survival in adult patients aged 20-75 with newly diagnosed FLT3-ITD positive AML.

The primary endpoint of the study was OS. Secondary endpoints included event-free survival, post-induction rate of complete remission (CR), 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, also were evaluated.⁶

QuANTUM-First enrolled 539 patients at 193 study sites across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.  

About FLT3-ITD Positive Acute Myeloid Leukemia

Approximately 487,000 new cases of leukemia were diagnosed globally in 2022, leading to more than 305,000 deaths.⁷ AML accounts for approximately 23% of total leukemia cases worldwide.⁸ The disease arises from the abnormal proliferation and differentiation of myeloid stem cells in the bone marrow.² In Canada, 1,286 people died from AML in 2022 and it remains the second most commonly diagnosed blood cancer in the country.^9,10

About VANFLYTA

VANFLYTA is an oral, highly potent and selective type II FLT3 inhibitor approved in more than 30 countries in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as maintenance monotherapy following consolidation, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive based on the results from the QuANTUM-First trial.^1,3

VANFLYTA is an investigational medicine in all countries outside of Canada, Hong Kong, EU, Switzerland, Scotland, United Kingdom, Japan, and the U.S.

About the VANFLYTA Clinical Development Program

The VANFLYTA clinical development program includes the QuANTUM-Wild phase 3 trial in adult patients with newly diagnosed FLT3-ITD negative AML, a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe, Asia and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichi-sankyo.ca.

References

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VANFLYTA is a registered trademark of Daiichi Sankyo Co., Ltd., used by Daiichi Sankyo Pharma Canada Ltd. under license.

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