Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Recommends Granting a Marketing Authorisation for Quizartinib

It is intended for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML
02 Oct 2023
Targeted Therapy;  Molecular Oncology

On 14 September 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product quizartinib (Vanflyta), intended for the treatment of acute myeloid leukaemia (AML) that is FLT3-ITD positive.

The applicant for this medicinal product is Daiichi Sankyo Europe GmbH.

Vanflyta will be available as 17.7 mg and 26.5 mg film-coated tablets. The active substance of Vanflyta is quizartinib, a protein kinase inhibitor (ATC code: L01EX11). Quizartinib, together with its major metabolite AC886, inhibits the receptor tyrosine kinase FLT3 by preventing autophosphorylation of the receptor, thereby inhibiting further downstream FLT3 receptor signalling and blocking FLT3-ITD-dependent cell proliferation.

The benefit of Vanflyta is an increased survival rate (median overall survival of 31.9 months and 15.1 months respectively for quizartinib and placebo) when used in the approved indication, as shown in a randomised, double-blind, placebo-controlled, phase III study in adult patients with FLT3-ITD-positive AML.

The most common side effects are increased alanine aminotransferase, decreased platelet count, decreased haemoglobin, diarrhoea, nausea, abdominal pain, headache, vomiting and decreased neutrophil count.

The full indication is:

  • 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 AML that is FLT3-ITD positive.
  • Vanflyta should be prescribed by physicians experienced in the use of anticancer therapies.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.