Vanflyta scores a first with EU approval

Following US approval in the same indication earlier this year, Japanese drugmaker Daiichi Sankyo’s (TYO: 4568) Vanflyta (quizartinib) has now also been approved in the European Union (EU).

The drug has been authorized for use 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 leukemia (AML) that is FLT3-ITD positive.

Daiichi pointed out that Vanflyta is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25% to 30% of all new AML cases.