Quizartinib is the lead agent in the investigational AML Franchise of the Daiichi Sankyo Cancer Enterprise. A broad and comprehensive clinical development program is currently underway with quizartinib:
Pivotal Phase 3 Clinical Studies
QuANTUM-R: Single agent quizartinib versus salvage chemotherapy in relapsed/refractory FLT3-ITD AML. Data from QuANTUM-R was presented as a late-breaking oral presentation in the plenary program at the 23rd Congress of the European Hematology Association (EHA). (US, EU)
QuANTUM-First: Quizartinib in combination with induction and consolidation chemotherapy as well as a maintenance therapy for newly-diagnosed FLT3-ITD AML. For more information about QuANTUM-First, visit www.QuantumFirstStudy.com. (US, EU, Asia)
Phase 2 Clinical Studies
Relapsed/Refractory FLT3-ITD AML: Single agent quizartinib in relapsed/refractory FLT3-ITD AML (Japan)
Phase 1 Clinical Studies
Relapsed/Refractory and Newly-Diagnosed FLT3-ITD AML: Quizartinib in combination with milademetan (DS-3032) in relapsed/refractory FLT3-ITD AML or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy (US)
Quizartinib has been granted 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 U.S. Food and Drug Administration (FDA).
Quizartinib also has received Orphan Drug designation by both the FDA and the European Medicines Agency (EMA) for the treatment of AML.