Posted by Michael Wonder on 21 Apr 2023
Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML extended by FDA
20 April 2023 - Daiichi Sankyo today announced that the US FDA has extended the review period for 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.
The FDA has extended the PDUFA action date by three months to 24 July 2023 to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in this application. No additional efficacy or safety data has been requested.
