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 in adults aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018. The approval is principally based on the results of two phase III studies, VIALE-A and VIALE-C. Results of the VIALE-A study, which were published in the New England Journal of Medicine in August 2020, showed that Venclexta plus azacitidine significantly diminished the risk of death by 34% (overall survival; OS) compared with azacitidine alone (median OS = 14.7 months vs. 9.6 months; hazard ratio [HR] = 0.66; 95% CI, 0.52-0.85; P <.001).

Individuals treated with Venclexta plus azacitidine had significantly greater rates of complete remission (CR), 37% (95% CI, 31-43) compared with 18% (95% CI, 12-25) in individuals treated with azacitidine alone (P <.001). The Venclexta-plus-azacitidine combination also led to higher rates of CR and CR with partial haematologic recovery (CR + CRh), with the combination showing a CR + CRh of 65% compared with 23% for azacitidine alone (P <.001). The most frequent serious adverse reactions (≥5%), reported in 83% of individuals treated with Venclexta plus azacitidine, were low white blood cell count with fever (30%), pneumonia (22%), blood infection (excluding fungal;19%), and bleeding (6%).

For the VIALE-C study, approval was based on the rate and duration of CR. Results also indicated that 27% (95% CI, 20-35) of individuals treated with Venclexta plus LDAC attained a CR (average duration of CR [DOCR] = 11.1 months) versus. 7.4% (95% CI, 2.4-16) of individuals treated with LDAC alone (average DOCR = 8.3 months). The average OS for individuals treated with Venclexta plus LDAC was 7.2 months versus 4.1 months (HR = 0.75; 95% CI, 0.52-1.07; P = .114) for individuals treated with LDAC alone. The OS results were not statistically significant.

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