The drug was approved for FLT3-mutated acute myeloid leukemia in November based on response rate data, but the latest results show improvement on the gold-standard measure of overall survival.
The drug is the second FLT3 inhibitor to win approval, after Novartis' Rydapt in first-line disease. Daiichi Sankyo's quizartinib could present competition if it wins approval, but it would target a somewhat narrower population of FLT3-mutated patients.
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases