FDA Approves RYDAPT® for FLT3-Mutated Acute Myeloid Leukemia

The FDA on April 28, 2017 approved RYDAPT® (Midostaurin), a multikinase inhibitor, for the treatment of adult patients with newly diagnosed Acute Myeloid Leukemia (AML), who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard Cytarabine and Daunorubicin induction and Cytarabine consolidation. Activating mutations in the FLT3 receptor is the most common genetic abnormality in AML and is detected in approximately 30% of the patients. RYDAPT® along with chemotherapy significantly improved Overall Survival and represents a new standard of care for FLT3-mutated AML patients.