FDA Approves Frontline Venetoclax in AML

November 21, 2018 – The FDA has granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The approval is based on 2 phase Ib/II trials in this setting, the M14-358 study and the M14-387 study … (leggi tutto)