UK approves quizartinib for FLT3-ITD-positive AML

Acute myeloid leukaemia

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Daiichi Sankyo’s quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults with acute myeloid leukaemia (AML).

Each year in the UK around 3,100 people are diagnosed with AML.

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: “Our key priorities are keeping patients safe and enabling their access to high quality, safe and effective medical products. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.”

Quizartinib has been approved for adults who have AML with a mutation in the FLT3 gene called ‘FLT3-ITD’. The drug blocks the action of tyrosine kinases, the proteins responsible for the body producing large numbers of abnormal bone marrow cells. By slowing down or stopping the abnormal cells from dividing and growing uncontrollably, quizartinib helps immature cells grow into normal cells.

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

The study demonstrated a statistically significant improvement in overall survival (time from randomisation to death from any cause) for patients receiving quizartinib.

Patients receiving quizartinib had a median overall survival of 31.9 months compared to 15.1 months for those receiving the placebo.

Quizartinib was approved for this indication by the US Food and Drug Administration (FDA) in July 2023.

Diana Spencer, Senior Digital Content Editor, DDW

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