Targeted therapy for hard-to-treat leukaemia subtype approved in EU

Daiichi Sankyo’s VANFLYTA^® (quizartinib) is the first FLT3 inhibitor to be approved in the EU for newly diagnosed FLT3-ITD positive acute myeloid leukaemia (AML).

The European Commission (EC) has authorised the anti-cancer treatment 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 that is FLT3-ITD positive.

“With the approval of VANFLYTA in the EU, patients diagnosed with FLT3-ITD positive acute myeloid leukaemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype,” commented Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.

First targeted therapy for difficult-to-treat acute myeloid leukaemia subtype

VANFLYTA is an oral highly potent type II FLT3 inhibitor and the second innovative medicine from Daiichi Sankyo’s oncology pipeline approved in the EU.

The EMA’s human medicines committee (CHMP) committee gave a positive opinion for Vanflyta (quizartinib) in September 2023.

The EC’s decision is based on the results of the QuANTUM-First Phase III clinical trial, which were published in The Lancet, which demonstrated a 22 percent reduction in the risk of death compared to standard chemotherapy alone in patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia. In the trial, 539 patients were enrolled at 193 study sites across Asia, Europe, North America, Oceania and South America.

Median overall survival was 31.9 months for patients receiving VANFLYTA compared to 15.1 months for patients in the control arm at a median follow-up of 39.2 months.

FLT3-ITD positive acute myeloid leukaemia is an aggressive and historically difficult-to-treat disease subtype, Dr Richard Schlenk, Professor and Head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany stated. “VANFLYTA is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option” for newly diagnosed eligible patients.”