Posted by Michael Wonder on 21 Oct 2019
Daiichi Sankyo receives negative CHMP opinion for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
18 October 2019 - Global clinical development program of quizartinib continues with focus on newly-diagnosed FLT3-ITD AML with enrolment completed into pivotal phase 3 QuANTUM-First study.
Daiichi Sankyo Company today announced the CHMP of the EMA has adopted a negative opinion on the marketing authorisation application for quizartinib for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukaemia
The CHMP opinion is based on the submission of data from the global pivotal QuANTUM-R study of quizartinib. Results from QuANTUM-R were published in The Lancet Oncology.
