Posted by Michael Wonder on 04 Apr 2019
Daiichi Sankyo provides update on ongoing FDA review for quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new drug application of quizartinib, an investigational FLT3 inhibitor, currently under priority review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukaemia.
The new Prescription Drug User Fee Act action date is 25 August 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.
