On October 16, 2020, the FDA granted full approval of Venclexta® (venetoclax) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC), 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. Venclexta (venetoclax) was previously granted provisional approval in this setting under the FDA’s accelerated approval program.
“Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy. We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries.”