Is Quizartinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Quizartinib, including VANFLYTA (Prescription).

Is Quizartinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Quizartinib: Vanflyta.

Are there safety signals or safety updates for Quizartinib?

US FDA: 1 entry (latest 2026-04-13).

Active substance

Quizartinib

US FDA 1
EMA 2
Health Canada 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VANFLYTA	EQ 17.7MG BASE; EQ 26.5MG BASE	tablet · oral	DAIICHI SANKYO INC	Prescription	20 Jul 2023

EMA European Union — centrally authorised medicines

Vanflyta Daiichi Sankyo Europe GmbH · Authorised · authorised 6 Nov 2023 · ATC L01EX11

Therapeutic indication (EMA)

Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

Vanflyta Daiichi Sankyo Europe GmbH · Refused · ATC L01XE

Therapeutic indication (EMA)

Treatment of acute myeloid leukaemia.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VANFLYTA	02558351	17.7 MG	TABLET · ORAL	DAIICHI SANKYO PHARMA CANADA LIMITED
VANFLYTA	02558378	26.5 MG	TABLET · ORAL	DAIICHI SANKYO PHARMA CANADA LIMITED

Safety signals and safety-related labeling changes

US FDA 13 Apr 2026 VANFLYTA — safety-related labeling change
Labeling sections changed: Drug Interactions

All safety entries for quizartinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.