EMA grants accelerated review for quizartinib

6 November 2018

Japanese pharma major Daiichi Sankyo (TYO: 4568) says that the European Medicines Agency has 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.

Notwithstanding the positive news on Monday, Daiichi Sankyo’s share fell 2.50% to 4,093 yen, but rebounded 4.89% to 4,293 yen today

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.

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