Drug: PKC412 (Midostaurin, Novartis)
Status: Granted priority review to treat newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and advanced systemic mastocytosis
Significant Data:
- Priority review based on data from the largest clinical trials conducted to date in each indication
- RATIFY trial:
- PKC412 + standard chemotherapy versus placebo + standard chemotherapy was investigated in adult patients less than 60 years of age with FLT3-mutated AML
- Patients in the PKC412 arm experienced a