Quizartinib recommended for approval in EU by CHMP for patients with newly diagnosed FLT3-ITD positive AML

Daiichi Sankyo

15 September 2023 - Positive opinion based on QuANTUM-First results demonstrating quizartinib combined with standard chemotherapy improved overall survival.

Daiichi Sankyo announced that quizartinib has been recommended for approval in the European Union in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia that is FLT3-ITD positive.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , Europe