Daiichi Sankyo's Vanflyta (Quizartinib) Becomes First Oral FLT3 Inhibitor Approved in Japan for Relapsed/Refractory FLT3-ITD-Positive AML

Today, Daiichi Sankyo announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the marketing of Vanflyta (quizartinib), an oral FLT3 inhibitor developed by the company, for the treatment of patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) who harbor FLT3-ITD genetic mutations.

Acute Myeloid Leukemia (AML) is a rapidly progressive cancer of the blood and bone marrow, characterized by the rapid proliferation of malignant white blood cells. These abnormal cells not only fail to perform their normal functions but also impair the production of healthy blood cells. The 5-year survival rate for patients with AML is the lowest among all types of leukemia.

FLT3 gene mutations are the most common genetic alterations in patients with acute myeloid leukemia (AML). FLT3-ITD is the most prevalent FLT3 gene mutation, occurring in approximately one-quarter of AML patients. FLT3-ITD is a cancer driver associated with high leukemic burden and poor prognosis in AML patients.

Vanflyta is an oral FLT3 inhibitor. It has been granted Breakthrough Therapy Designation and Fast Track designation by the FDA.

The approval of Vanflyta in Japan was based on the results from the pivotal global Phase 3 QuANTUM-R clinical trial and a Phase 2 clinical trial involving Japanese patients. The results of the QuANTUM-R trial were recently published in *The Lancet Oncology*. The findings demonstrated that Vanflyta significantly improved overall survival compared to salvage chemotherapy. The median overall survival was 6.2 months in the Vanflyta group versus 4.7 months in the control group (HR: 0.75; 95% CI: 0.58, 0.98).

“The approval of Vanflyta provides patients with relapsed/refractory acute myeloid leukemia (R/R AML) harboring FLT3-ITD mutations with an important therapeutic option that targets the molecular mechanisms of the disease and improves patient survival compared with chemotherapy,” said Dr. Wataru Takasaki, Head of Oncology at Daiichi Sankyo. “We are committed to launching seven new molecular entities (NMEs) for cancer treatment by 2025. Vanflyta represents the first step toward achieving this goal.”

References:

[1] Daiichi Sankyo's VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML. Retrieved June 18, 2019, from https://www.prnewswire.com/news-releases/daiichi-sankyos-vanflyta-receives-approval-in-japan-for-the-treatment-of-relapsedrefractory-flt3-itd-aml-300870240.html

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