Daiichi Sankyo Submits NDA for Quizartinib in China for FLT3-ITD-Positive Acute Myeloid Leukemia

Today (January 18), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,The marketing application for quizartinib hydrochloride tablets, a Class 5.1 new drug submitted by Daiichi Sankyo, has been accepted.Public information shows that this is a FLT3 inhibitor Vanflyta (quizartinib), which was approved by the U.S. FDA for treatment in July 2023.WithFLT3-ITDFor newly diagnosed acute myeloid leukemia (AML) adult patients with positive mutations, it is used in three treatment phases for AML patients — induction, consolidation, and maintenance therapy.。

Screenshot source:CDE Official Website

AML is one of the most common types of leukemia in adults. As a rapidly progressing cancer of the blood and bone marrow, the cancerous white blood cells in AML patients grow rapidly, not only failing to function properly but also interfering with the production of normal blood cells.

QuizartinibIt is an orally administered, selective FLT3 inhibitor.FLT3 is a transmembrane receptor tyrosine kinase protein, typically expressed by hematopoietic stem cells, promotes cell survival, growth, and differentiation through various signaling pathways, playing a crucial role in cell development.FLT3Gene mutations are the most common genetic variations in AML patients.Up to 37% of newly diagnosed AML patients carryFLT3Gene mutations, about 80% of which areFLT3-ITD mutation,FLT3-ITD mutations can promote cancer growth, leading to an increased risk of recurrence and shorter overall survival.

July 2023,FDAApprovalQuizartinibIn combination with standard chemotherapy, as well as maintenance monotherapy following consolidation chemotherapy, for the treatment of patients confirmed to haveFLT3-ITD mutation-positive newly diagnosed acute myeloid leukemia (AML) adult patients.According to an earlier press release from Daiichi Sankyo,This approval is based on the QuANTUM-First trial results, a randomized, double-blind, placebo-controlled global Phase 3 clinical trial, which included 539 newly diagnosedFLT3-ITD AML Patient Enrollment。

Data analysis shows,Compared with standard treatment control, receivingQuizartinibCombined standard induction and consolidation chemotherapy treatment, followed by continuedQuizartinibNewly diagnosed with single-agent therapyFLT3-ITD-positive patients showed a 22% reduction in mortality risk.. Although the complete response (CR) rates were similar between the two trial groups,AcceptQuizartinibThe median duration of CR in treated patients reached 38.6 months, more than three times longer than the value in patients treated with placebo + standard chemotherapy (12.4 months).

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform,This study, named QuANTUM-First, has also been completed in China (CTR20170661).

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website

In addition to the QuANTUM-First study, Daiichi Sankyo has also registered another international multicenter (including China) phase 3 clinical trial of quizartinib, which is for newly diagnosed FLT3-ITD.NegativeA Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial (QuANTUM-Wild) Evaluating Quizartinib in Combination with Induction and Consolidation Chemotherapy and Quizartinib as Maintenance Therapy in Adult Patients with Acute Myeloid Leukemia (AML). The primary endpoint of the study is Overall Survival (OS), and the study is planned to be conducted across 260+ research centers globally, with an intended enrollment of 700 participants internationally.