FDA grants leukaemia drug ‘breakthrough’ status

A leukemia drug has been granted ‘breakthrough therapy’ status by the US drug regulator. Daiichi Sankyo announced that it had been awarded the designation by the US Food and Drug Administration (FDA) for quizartinib, which is used to treat acute myeloid leukemia (AML). This means the product is likely to be brought to market swiftly, on approval. The move follows the promising results of a phase 3 trial, which revealed that quizartinib prolongs overall survival as an oral, single agent compared to chemotherapy in adults with relapsed/refractory FLT3-ITD AML. FLT3 mutations are among the most common abnormalities in AML and have historically pointed to a poor prognosis.