5 November 2018 - Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD AML.

Daiichi Sankyo has announced that the European Medicines Agency (EMA) validated for review and granted accelerated assessment to the Marketing Authorization Application (MAA) for quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive.

Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Accelerated assessment is given to products expected to be of major interest for public health and therapeutic innovation and can significantly reduce the review timelines.

The EU MAA is based on results of the pivotal phase 3 QuANTUM-R study of quizartinib, which was the first randomized phase 3 study to show that a FLT3 inhibitor prolonged overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML. Topline results of the phase 3 QuANTUM-R study were presented during the plenary program at the 23rd Congress of the European Hematology Association in June 2018.

Read Daiichi Sankyo press release