Astellas' AML drug wins over CHMP — strengthening lead on Daiichi Sankyo
Less than a year after scoring a fast FDA OK for its pioneering acute myeloid leukemia drug gilteritinib, Astellas has snapped up a positive recommendation from European regulators following an accelerated assessment.
The CHMP thumbs up widens the gap between Astellas and Daiichi Sankyo, which has run into a roadblock at the FDA when trying to field its own FLT3 targeted therapy after being green-lighted in Japan.
Daiichi’s drug, quizartinib, has also nabbed speedy review at the EMA.
Up to 30% of AML patients have an FLT3 mutation, which stimulates the growth of abnormal leukemia cells. Novartis’ Rydapt is approved on both sides of the Atlantic to treat the same group in combination with chemotherapy.
The marketing authorization for gilteritinib — branded Xospata — will cover relapsed or refractory cases in adults.
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