Daiichi planning regulatory submissions for AML candidate

Daiichi Sankyo Co. Ltd. (Tokyo:4568) said quizartinib met the primary endpoint of improving overall survival (OS) vs. salvage chemotherapy in the Phase III QuANTUM-R trial to treat relapsed or refractory acute myelogenous leukemia. The company plans to submit worldwide regulatory applications for the FMS-like tyrosine kinase 3 (FLT3; CD135) inhibitor in the indication, but declined to disclose a timeline.

QuANTUM-R enrolled 367 patients with relapsed or refractory FLT3-internal tandem duplication (ITD) mutation-positive AML following standard first-line AML therapy with or without hematopoietic stem cell transplantation (HSCT). Daiichi plans to present data from the trial at an upcoming medical meeting...