The European Commission (EC) has granted approval for Daiichi Sankyo’s Vanflyta (quizartinib) for newly diagnosed fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive acute myeloid leukaemia (AML) in adults.

Vanflyta is approved along with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by maintenance therapy with Vanflyta alone.

The latest development comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion for granting approval. 

This approval in the European Union (EU) is based on data from the double-blind, randomised, international, placebo-controlled Phase III QuANTUM-First clinical trial of the Vanflyta combination regimen.

It enrolled 539 subjects at 193 trial centres in 26 countries across Europe, Asia, Oceania and North and South America. 

Trial data showed that the treatment offered a 22% decline in mortality risk versus standard chemotherapy alone. 

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At 39.2 months of median follow-up, subjects in the Vanflyta arm had a median overall survival of 31.9 months versus 15.1 months in the control arm. 

In the trial, Vanflyta’s safety profile was in line with previously reported trial data with no new safety signals detected. 

An oral inhibitor of type II FLT3, Vanflyta is designed for FLT3-ITD-positive AML patients.

Daiichi Sankyo oncology business global head, president and CEO Ken Keller stated: “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. 

“Vanflyta is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer.”