UK Approval for Daiichi Sankyo's Quizartinib in Blood Cancer

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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization to Daiichi Sankyo UK Ltd. for the medicine quizartinib (Vanflyta) to be used in conjunction with chemotherapy as first-line treatment for adults diagnosed with acute myeloid leukemia (AML). This approval was issued on March 11th, 2024.

AML is a fast-progressing and aggressive form of blood cancer that necessitates prompt treatment. In the UK, roughly 3,100 people are diagnosed with AML each year, which can affect the various types of blood cells in the bone marrow, leading to bleeding, anemia, and infections.

Julian Beach, MHRA interim executive director of healthcare quality and access, stated, "Our primary goals are to ensure patients' safety and provide them access to high-quality, safe, and effective medical products. We are confident that the necessary regulatory standards for approving this medication have been met. As with all medications, we will closely monitor its safety."

Quizartinib has been authorized for use as first-line treatment in conjunction with chemotherapy for FLT3-ITD, a mutation in the FLT3 gene, in adults with AML. Treatment is taken orally once a day, at roughly the same time for two weeks, during each chemotherapy cycle. The prescribing physician will determine the appropriate dosage of quizartinib and the duration of treatment. Following the completion of chemotherapy, the physician may continue the patient's treatment with quizartinib.

Quizartinib inhibits the activity of tyrosine kinases, the proteins responsible for the body producing many abnormal bone marrow cells that do not mature to become healthy cells.