The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).
The Agency issued its opinion on 17 October 2019. The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Questions and answers on the refusal of the marketing authorisation for Vanflyta (quizartinib) (PDF/72.47 KB) (updated)Adopted
First published: 18/10/2019
Last updated: 06/01/2020
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Leukemia, Myeloid, Acute
|Anatomical therapeutic chemical (ATC) code||
Daiichi Sankyo Europe GmbH
|Date of opinion||
|Date of refusal of marketing authorisation||