Posted by Michael Wonder on 24 Oct 2022
Quizartinib granted priority review in the US for patients with newly diagnosed FLT3-ITD positive acute myeloid leukaemia
24 October 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone.
Daiichi Sankyo received notification of acceptance by the US FDA of the new drug application of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia that is FLT3-ITD positive.
