MedPath
EMA Product

Vanflyta

Product approved by European Medicines Agency (EU)

Basic Information

Vanflyta

Regulatory Information

EMEA/H/C/005910

Authorised

November 6, 2023

September 14, 2023

3

December 18, 2024

Company Information

Germany

Zielstattstrasse 48 81379 Munich

Daiichi Sankyo Europe GmbH

Drug Classification

Additional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication 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.

Overview Summary

Vanflyta is a cancer medicine used to treat adults who have been newly diagnosed with acute myeloid leukaemia (AML), a cancer of the white blood cells. It is only given to those patients whose cancer cells have a particular change (mutation) known as ITD in the gene for a protein called FLT3. Vanflyta is used together with cytarabine and anthracycline (other cancer medicines, also called chemotherapy) at induction (start of treatment) . After induction it is used in combination with cytarabine alone (consolidation). It is then used on its own as maintenance therapy. Vanflyta contains the active substance quizartinib.

© Copyright 2025. All Rights Reserved by MedPath