FDA extends review of NDA for AC 220 in acute myeloid leukemia.- Daiichi Sankyo

Daiichi Sankyo announced that the FDA has extended the review period for the New Drug Application (NDA) of AC 220 (quizartinib), an investigational FLT3 inhibitor, currently under Priority Review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The new Prescription Drug User Fee Act (PDUFA) action date is August 25, 2019. The FDA extended the action date by three months to allow time to review additional data submitted by Daiichi Sankyo in association with an FDA request. The FDA accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) on 21 November 2018.

The NDA is based on results of the pivotal phase III QuANTUM-R study of quizartinib, which was the first randomized phase III study to show that a FLT3 inhibitor prolonged overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML. Topline results of the phase III QuANTUM-R study were presented during the plenary program at the 23rd Congress of the European Hematology Association.

Comment: Regulatory marketing applications for quizartinib are currently under expedited review in the U.S, Japan and EU. Quizartinib has been granted Priority Review and Breakthrough Therapy designation for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, and Fast Track designation for the treatment of relapsed/refractory AML by the FDA. Quizartinib also has been granted accelerated assessment by the European Medicines Agency for the treatment of adults with relapsed or refractory AML which is FLT3-ITD positive, and granted Orphan Drug designation by both the FDA and the European Commission for the treatment of AML and by the Japan Ministry of Health, Labour and Welfare for the treatment of FLT3-mutated AML.