VENCLYXTO in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
For newly diagnosed adult patients with AML who are ineligible for intensive chemotherapy1
SIGNIFICANTLY EXTENDS OVERALL SURVIVAL* IN FIRST-LINE TREATMENT WITH VENCLYXTO PLUS AZACITIDINE VERSUS AZACITIDINE ALONE1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
MAXIMISES OVERALL SURVIVAL VS AZA ALONE
- 5.1-month increase in median overall survival vs AZA alone (14.7 months vs 9.6 months, respectively [95% CI: 0.52-0.85; P<0.001])1
MAINTAINS REMISSION FOR LONGER
- More than DOUBLE the remission rate vs AZA alone (66% CR+CRi vs 28%, respectively; P<0.001)1,2
- Higher remission rates across mutational subgroups vs AZA alone1,2
- Longer remission rates among patients who achieved CR+CRi vs AZA alone (17.5 months vs 13.4 months, respectively)1
MINIMISES TRANSFUSION DEPENDENCE
- RBC or platelet transfusion independence achieved in ≥60% of patients1
MANAGEABLE ADVERSE EVENT PROFILE
- Adverse events can be managed with appropriate dose-modification protocols1
*VIALE-A was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7; HR=0.66; P<0.001).1
AML=acute myeloid leukaemia; AZA=azacitidine; BCL-2=B-cell lymphoma 2; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; HR=hazard ratio; RBC=red blood cells.
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. December 2022. 2. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;383(7):617-629. doi:10.1056/NEJMoa2012971
ALL-VNCAML-220066 October 2023