Daiichi Sankyo Company, Limited announced quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD Acute Myeloid Leukemia (AML).
Quizartinib is the first FLT3 inhibitor to enhance overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory AML with FLT3-ITD, an underlying driver of this subtype of AML.
It helps to bring new treatment options to patients with serious diseases. The inhibitor is the result of the pivotal phase 3 QuANTUM-R study of quizartinib.
QuANTUM-R is the first randomised phase 3 study to show that a FLT3 inhibitor, quizartinib, prolongs overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML.
The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program.
The frequency of treatment-emergent adverse events was comparable between patients who received single agent quizartinib (n=241) and those who received salvage chemotherapy (n=94).
The most common adverse events (>30 percent, any Grade) in patients treated with quizartinib included nausea, thrombocytopenia, fatigue, musculoskeletal pain, pyrexia, anemia, neutropenia, febrile neutropenia, vomiting and hypokalemia.
QuANTUM-R, a pivotal, global, phase 3, open-label randomized study had enrolled 367 patients with FLT3-ITD-mutated AML who were refractory to or in relapse (with duration of remission of six months or less) following standard first-line AML therapy with or without HSCT.
Patients were randomised in a 2:1 ratio to receive either single agent oral quizartinib or salvage chemotherapy.