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.
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