Date: 2016-10-11
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Daiichi Sankyo (Japan)
Product: quizartinib (AC220)
Action
mechanism: tyrosine kinase inhibitor. Quizartinib is an investigational oral small molecule that potently and selectively inhibits FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication), which is a growth driver of abnormal cells that contribute to the development of AML. Quizartinib has been granted Orphan Drug Designation by the FDA and European Medicines Agency (EMA) for the treatment of AML. Quizartinib also has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory AML. Quizartinib has been developed by Ambit Biosciences. Daiichi Sankyo acquired the company in November 2014,
Disease: acute myeloid leukemia
Therapeutic area: Cancer - Oncology
Country: Canada, Hungary, USA
Trial
details: QuANTUM-First is a randomized, double-blind, placebo-controlled study evaluating quizartinib in combination with induction and consolidation chemotherapy and as maintenance monotherapy in patients with newly-diagnosed FLT3-ITD+ AML. The primary endpoint of the study is event-free survival. Secondary endpoints include overall survival, complete remission rate, composite complete remission rate and the percentage of subjects achieving a complete remission with no evidence of minimal residual disease. (NCT02668653)
Latest
news: * On October 11, 2016, Daiichi Sankyo announced that the first patient has been enrolled in the global phase 3 QuANTUM-First study evaluating the oral FLT3-ITD inhibitor quizartinib in patients with newly-diagnosed FLT3-ITD-positive (+) acute myeloid leukemia (AML). QuANTUM-First is expected to enroll more than 500 patients between 18 and 75 years of age in the Americas, Europe and Asia-Pacific.
