Regulatory green light in China lifts Daiichi Sankyo’s Vanflyta to frontline AML care

Daiichi Sankyo’s FLT3 inhibitor Vanflyta (quizartinib) has received Chinese approval as the first targeted therapy of its kind for newly diagnosed FLT3-ITD positive acute myeloid leukemia, potentially expanding the drug’s global footprint beyond Japan and the US.

Edited by ad hoc news New Releases & Launches Desk. Reviewed before publication on 06/16/2026 at 2:45 AM ET. Details in the imprint.

Daiichi Sankyo’s FLT3 inhibitor Vanflyta (quizartinib) has just secured Chinese regulatory approval as the first and only FLT3 inhibitor indicated for newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) in adults when used with standard induction, consolidation and maintenance therapy, significantly expanding its commercial and clinical reach in a key oncology market. According to Daiichi Sankyo’s official announcement, China’s National Medical Products Administration (NMPA) cleared the drug on June 15, 2026, based on the global phase 3 QuANTUM-First study.

How Vanflyta fits into frontline AML treatment

Vanflyta is an oral, highly selective type II FLT3 inhibitor designed to block signaling in leukemic cells that harbor internal tandem duplication (ITD) mutations in the FLT3 gene, a high-risk subset that occurs in roughly 20 to 30 percent of AML patients and is generally associated with poor prognosis and higher relapse rates. When combined with standard cytarabine plus anthracycline induction chemotherapy, followed by cytarabine consolidation and continued as single-agent maintenance, quizartinib significantly improved overall survival compared with standard chemotherapy alone in adults with newly diagnosed FLT3-ITD positive AML, as demonstrated in the randomized, double-blind QuANTUM-First trial that enrolled more than 530 patients worldwide. In that study, Vanflyta reduced the risk of death by 22 percent versus control (hazard ratio 0.78; 95 percent confidence interval 0.62 to 0.98), with median overall survival of 31.9 months for the quizartinib arm compared with 15.1 months for the chemotherapy-only group at a median follow-up of 39.2 months, supporting the NMPA’s decision to bring the regimen into the Chinese first-line standard of care.

Before the new Chinese indication, quizartinib had already been introduced in Japan as a monotherapy for relapsed or refractory FLT3-ITD positive AML and was later approved in the United States in July 2023 as Vanflyta for use in combination with standard induction and consolidation chemotherapy, followed by maintenance, in newly diagnosed adult patients with FLT3-ITD positive AML. The Chinese approval effectively extends the geographic footprint of the same treatment concept, giving hematologists in one of the world’s largest oncology markets an additional targeted option alongside other FLT3 inhibitors such as midostaurin and gilteritinib, and aligning the market more closely with evolving international guidelines that emphasize mutation-directed therapy in AML. For patients, especially those treated at major Chinese hematology centers, the availability of quizartinib-based regimens could help narrow historical survival gaps seen between FLT3 wild-type and FLT3-ITD mutated disease, although real-world outcome data will be critical in confirming whether the trial results translate into routine practice.

From a commercial standpoint, the new label in China adds another major revenue pillar on top of existing sales in Japan and the US, reinforcing oncology as a core growth driver within Daiichi Sankyo’s portfolio, which also includes antibody-drug conjugates such as trastuzumab deruxtecan co-developed with AstraZeneca. While the company has not disclosed detailed sales targets for Vanflyta in China, the broader FLT3 inhibitor segment is expected to expand as more patients undergo routine genomic testing at diagnosis and as payers in large emerging markets gradually incorporate precision oncology products into reimbursement frameworks, offering medium-term volume growth potential if pricing and access are managed effectively. For healthcare providers, the introduction of quizartinib may require updates to diagnostic workflows to ensure timely FLT3 mutation testing and appropriate risk stratification so that eligible patients can receive the drug early in their treatment course.

For Daiichi Sankyo, the approval underscores the strategic importance of Asia-Pacific markets in its hematology and oncology roadmap, complementing its global antibody-drug conjugate ambitions and strengthening the company’s presence in targeted small-molecule therapies. Shares of Daiichi Sankyo (ISIN JP3475350009) closed on the Tokyo Stock Exchange at JPY 2,546.0 on June 15, 2026, according to Reuters market data. Reuters also highlighted the Chinese approval as a notable catalyst in the context of the company’s oncology franchise and recent share price move.

Vanflyta for AML in brief: key product facts

• Product: Vanflyta (quizartinib)
• Manufacturer: Daiichi Sankyo Co., Ltd.
• Category: New Release/Launch - oncology prescription drug
• Launch date: June 15, 2026 approval for newly diagnosed FLT3-ITD positive AML in China
• MSRP / Price: Not publicly disclosed; pricing subject to Chinese hospital and reimbursement frameworks
• Availability: Hospital and specialist hematology centers in China following NMPA approval; already marketed in Japan and the US for FLT3-ITD positive AML
• Target audience: Adult patients with newly diagnosed or relapsed/refractory FLT3-ITD positive acute myeloid leukemia, treated under specialist supervision
• Key differentiator / USP: First and only FLT3 inhibitor approved in China for newly diagnosed FLT3-ITD positive AML in combination with standard chemotherapy and as maintenance, backed by QuANTUM-First overall survival data

This article was a.i.-assisted and editorially reviewed. Product information without warranty; prices and availability may change at short notice. Not investment advice and not a buy or sell recommendation. Trading involves risk up to and including the total loss of invested capital.