Vanflyta (quizartinib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- quizartinib
- Company
- Daiichi Sankyo Europe GmbH
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid
- CHMP opinion
- Thu 14 Sep 2023
- EU approval
- Mon 06 Nov 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005910
- ATC
- L01EX11
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Vanflyta Refused · Daiichi Sankyo Europe GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.