The FDA granted accelerated approval to venetoclax (Venclexta, AbbVie/Genentech) for use in combination with azacitidine (Vidaza, Celgene), decitabine (Dacogen, Eisai) or low-dose cytarabine in the treatment of newly diagnosed acute myeloid leukemia (AML) in older adults and those unable to receive intensive induction chemotherapy.
The approval was based on two non-randomized, open-label trials in patients who had newly diagnosed AML and were at least 75 years of age or had comorbidities that