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Health Canada has approved a quizartinib-based regimen for the treatment of patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia.
FLT3-ITD–positive AML | Image
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Health Canada has approved quizartinib (Vanflyta) plus standard cytarabine and anthracycline induction with standard cytarabine consolidation chemotherapy, followed by quizartinib monotherapy as maintenance, for the treatment of adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia (AML).1 A validated test is necessary to confirm the FLT3-ITD status.
The regulatory decision was based on data from the phase 3 QuANTUM-First trial (NCT02668653), which evaluated the combination of cytarabine/anthracycline induction and cytarabine consolidation, continued as maintenance monotherapy.2 Data revealed that the regimen demonstrated a 22.4% reduction in the risk of death vs standard chemotherapy alone among patients with newly diagnosed FLT3-ITD–positive AML (HR, 0.78; 95% CI, 0.62-0.98; 2-sided P = .0324). Of note, at a median follow-up of 39.2 months, the median overall survival (OS) was 31.9 months (95% CI, 21.0-not evaluable) for patients treated with quizartinib (n = 268) compared with 15.1 months (95% CI, 13.2-26.2) for those in the control arm (n = 271).
“The approval of [quizartinib] 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 [of leukemia],” Brian Leber, MD, FRCP, a professor of medicine in the Department of Medicine at McMaster University in Ontario, stated in a news release.1 “In the QuANTUM-First trial, [quizartinib] added to standard chemotherapy and continued as maintenance resulted in longer remission and prolonged OS, and it will be a much-needed new treatment option that has the potential to change the way FLT3-ITD–positive AML is treated.”
In July 2023, the FDA approved quizartinibplus standard cytarabine/anthracycline induction, cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy for the treatment of adult patients with FLT3-ITD–positive AML detected by an FDA-approved test.3 The FDA’s decision was also supported by data from the QuANTUM-First study.
Notably, in QuANTUM-First, 55% of patients from the quizartinib arm and 62% of those from the placebo arm discontinued the study, mostly due to death (90% vs 94%) or withdrawal of consent (9% vs 5%).2 A similar proportion of patients from both arms experienced at least 1 adverse effect (AE; 100% vs 99%) and 1 grade 3 or higher AE (92% vs 90%). The most common grade 3/4 AEs included febrile neutropenia, hypokalemia, and pneumonia in both groups; another common grade 3/4 AE in the quizartinib arm was neutropenia.
“Despite recent advances in AML treatment, patients with AML bearing FLT3-ITD mutations still face a challenging prognosis,” Andre Schuh, MD, FRCPC, a clinician investigator at the Cancer Clinical Research Unit at Princess Margaret Cancer Centre in Ontario, stated in the news release.1 “The approval of [quizartinib] offers a promising step forward, bringing hope for better outcomes in this high-risk patient population. As a new option for newly diagnosed FLT3-ITD–positive AML, [quizartinib] has the potential to redefine how this aggressive disease is treated in Canada.”
The randomized, placebo-controlled, double-blind study compared the quizartinib-based regimen with placebo in patients with newly diagnosed FLT3-ITD–positive AML at 193 hospitals and clinics in 26 countries across Europe, North America, Asia, Australia, and South America.2 Patients included on the trial were 18 to 75 years of age and were randomly assigned 1:1 to receive quizartinib or placebo, stratified by region, age, and white blood cell count at diagnosis.
Patients received induction therapy with cytarabine at 100 mg/m2 per day in a continuous intravenous (IV) infusion from days 1 to 7 plus IV daunorubicin at 60 mg/m2 per day or idarubicin at 12 mg/m2 per day on days 1, 2, and 3, followed by once-daily oral quizartinib at 40 mg or placebo starting on day 8 for 14 days. Patients with complete response (CR) or CR with incomplete neutrophil or platelet recovery then received standard consolidation therapy with high-dose cytarabine plus quizartinib at 40 mg once daily or placebo, allogeneic hematopoietic stem cell transplantation, or both, followed by continuation of quizartinib or placebo alone for a maximum of 3 years.
“The approval of [quizartinib] in Canada enables patients diagnosed with FLT3-ITD–positive AML to receive a targeted therapy specifically developed for their disease subtype,” Fatih Yadikardeş, a country manager for Canada at Daiichi Sankyo, added in the news release.1 “This milestone reflects our commitment to transforming cancer therapy, [advancing] innovation in hematology and oncology, and creating new standards of care for patients.”
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