Indication: VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. 1

VIALE-A: A randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 study that evaluated the efficacy and safety of VENCLEXTA (venetoclax tablets) in combination with azacitidine (VEN+AZA; N=286) vs placebo with azacitidine (PBO+AZA; N=145) in adults with newly diagnosed AML who were ≥75 years of age, or had comorbidities that precluded the use of intensive induction chemotherapy. 1

*See NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for AML, Version 3.2021, for complete recommendations. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Actionable mutations include IDH1/2 and FLT3.
CI=confidence interval; HR=hazard ratio; IDH=isocitrate dehydrogenase; FLT=fms-like tyrosine kinase.