By Fineline Cube The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO: 4568) for its type II FLT3 inhibitor, Vanflyta (quizartinib), as a maintenance treatment following consolidation chemotherapy for newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive in adult patients.
Phase III Study Results and Approval Basis
The approval is backed by compelling results from a Phase III study, which demonstrated that the treatment regimen with Vanflyta led to a 22% reduction in the risk of death and a three-fold increase in the median duration of complete response (CR) when compared to chemotherapy alone. This significant improvement in outcomes positions Vanflyta as a valuable addition to the treatment arsenal for FLT3-ITD positive AML patients.
Implications for AML Treatment and Patient Outcomes
The clearance of Vanflyta by the FDA marks a significant advancement in the treatment options for adult patients with FLT3-ITD positive AML. By offering a maintenance treatment that can extend the duration of complete response and reduce the risk of death, Vanflyta has the potential to significantly impact patient outcomes and improve survival rates in this patient population.-Fineline Info & Tech