Daiichi Sankyo`s Vanflyta (quizartinib) Receives Approval in Europe
VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML
Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML
The addition of quizartinib (Vanflyta) to induction and consolidation chemotherapy, followed by single-agent quizartinib for up to 36 cycles, improved survival outcomes vs placebo in patients with FLT3 ITD–mutated, newly diagnosed acute myeloid leukemia (AML), according to a presentation given by Harry P. Erba, MD, PhD at the 2023 SOHO Annual Meeting. This indicates its potential role as a standard of care in a population with historically poor prognosis.
The addition of quizartinib (Vanflyta) to standard induction and consolidation chemotherapy with idarubicin plus cytarabine (7+3) followed by maintenance therapy led to an improvement in event-free survival (EFS) and showed an early trend toward improved overall survival (OS) compared with placebo plus chemotherapy in patients with FLT3-ITD wild-type acute myeloid leukemia (AML), according to interim data from the phase 2 QUIWI trial (NCT04107727).
VANFLYTA® (quizartinib) Now Available from Onco360
July 20 (Reuters) - Daiichi Sankyo (4568.T) said the U.S. health regulator has approved its drug for treating newly diagnosed patients suffering from an aggressive type of blood cancer, pitting the treatment against those from rivals Novartis (NOVN.S) and Astellas (4503.T).
Daiichi Sankyo said the FDA needs more time to review the NDA for its FLT3 drug quizartinib, extending the PDUFA date by three months until July 24.
TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive. The application has been granted Priority Review.