Daiichi Sankyo Launches Second-Generation FLT3 Inhibitor Vanflyta (Quizartinib) in Japan for Relapsed/Refractory FLT3-ITD Acute Myeloid Leukemia

Daiichi Sankyo Announces Launch of Oral FLT3 Inhibitor Vanflyta (quizartinib) in Japan for the Treatment of Adult Patients with Relapsed/Refractory FLT3-ITD Acute Myeloid Leukemia (AML)

Vanflyta received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in June this year, marking the drug’s first regulatory approval worldwide. This approval was based on data from the global pivotal Phase III QuANTUM-R clinical trial and a Phase II clinical trial conducted in Japanese patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

Notably, the QuANTUM-R study is the first randomized Phase III trial to demonstrate that a FLT3 inhibitor, as an oral monotherapy, significantly prolongs overall survival compared with chemotherapy in patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). In this study, oral Vanflyta monotherapy significantly reduced the risk of death by 24% compared with salvage chemotherapy (HR=0.76, p=0.0177, 95% CI: 0.58–0.98) and significantly prolonged overall survival (median OS: 6.2 months [two-sided 95% CI: 5.3–7.2] vs. 4.7 months [two-sided 95% CI: 4.0–5.5]). The estimated 1-year survival rate was 27% in the Vanflyta group versus 20% in the salvage chemotherapy group. Regarding safety, the most common adverse drug reactions in patients treated with Vanflyta were nausea (33.2%, 80/241), QT interval prolongation on electrocardiogram (24.9%, 60/241), anemia (24.9%, 60/241), and thrombocytopenia (21.2%, 51/241).

Currently, Vanflyta is also undergoing accelerated assessment by the European Medicines Agency (EMA). Regarding U.S. regulatory matters, the FDA extended the review period for the New Drug Application (NDA) by three months in April this year, until August 25, 2019. According to the statement released at that time, the FDA needed time to review additional data submitted by Daiichi Sankyo related to the FDA's requirements. However, in June of this year, the FDA issued a Complete Response Letter (CRL), rejecting the approval of Vanflyta.

Vanflyta’s active pharmaceutical ingredient, quizartinib, is a second-generation FLT3 inhibitor. This oral small-molecule receptor tyrosine kinase inhibitor selectively targets and inhibits FLT3. In the United States, the FDA has granted quizartinib Breakthrough Therapy designation for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) and Fast Track designation for the treatment of relapsed/refractory AML. Furthermore, quizartinib has been granted orphan drug designation for the treatment of AML in both the United States and the European Union, and in Japan for the treatment of FLT3-mutated AML.

Acute myeloid leukemia (AML) is an aggressive cancer of the blood and bone marrow, characterized by the uncontrolled proliferation and accumulation of dysfunctional malignant white blood cells, which impairs the production of normal blood cells. FLT3 gene mutations are among the most common genetic abnormalities in AML, with FLT3 internal tandem duplication (FLT3-ITD) being the most prevalent FLT3 mutation, affecting approximately one-quarter of AML patients. FLT3-ITD is a driver mutation associated with high leukemic burden and poor prognosis, significantly impacting disease management in AML patients. Compared with AML patients without the FLT3-ITD mutation, those with FLT3-ITD have a poorer overall prognosis, including increased rates of relapse, higher risk of death post-relapse, and a greater likelihood of relapse after hematopoietic stem cell transplantation.

Original Source: Daiichi Sankyo Launches FLT3 Inhibitor VANFLYTA® in Japan for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

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