Adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia who received the investigational compound PKC412 (midostaurin), plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival (HR=0.77, p=0.0074), compared to those treated with standard induction and consolidation chemotherapy alone.
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
