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Quizartinib Receives Japanese Approval in Relapsed/Refractory FLT3+ AML

Gina Columbus @ginacolumbusonc
Published: Tuesday, Jun 18, 2019

The Ministry of Health, Labor and Welfare (MHLW) of Japan has approved quizartinib (Vanflyta) for the treatment of adult patients with relapsed/refractory FTL3-ITD–positive acute myeloid leukemia (AML), as detected by an MHLW-approved assay.1

The approval of the second-generation FLT3 inhibitor is mostly based on the phase III findings of the QuANTUM-R trial, as well as a phase II study, which demonstrated that oral quizartinib monotherapy showed a statistically significant improvement in overall survival (OS) compared with chemotherapy in this patient population.2

“With the approval of Vanflyta, patients with relapsed/refractory FLT3-ITD AML in Japan will now have access to this important new treatment option that specifically targets the underlying driver of disease, and has a proven survival benefit compared to chemotherapy,” Wataru Takasaki, PhD, corporate officer, head of Oncology Function, and head of R&D Division in Japan, Daiichi Sankyo, the developer of quizartinib, in a press release. “We are proud that Vanflyta is the first of seven new molecular entities we are committed to delivering by 2025 with the goal of transforming science into innovative treatments for patients with cancer.”

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