BRIEF—MHRA approves Vanflyta and Velspity

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Japanese drugmaker Daiichi Sankyo’s (quizartinib) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukemia (AML).

Quizartinib has been approved to be used alongside chemotherapy as first line treatment for adults who have AML with a mutation in the FLT3 gene called ‘FLT3-ITD’.

This regulatory approval is supported by evidence from a randomized, double-blind, placebo-controlled, Phase III clinical trial involving 539 adult patients (aged between 18 and 75 years) newly diagnosed with FLT3-ITD positive AML.