For newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
*VIALE-A was a randomized (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 [95% CI: 0.52-0.85; P<0.001]).1
†VIALE-C was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus LDAC was 7.2 months (95% CI: 5.6-10.1) vs 4.1 months for LDAC alone (95% CI: 3.1-8.8) (HR=0.75 [95% CI: 0.52-1.07; P=0.114]).1
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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BCL-2=B-cell lymphoma 2; AZA=azacitidine; LDAC=low-dose cytarabine; CI=confidence interval; HR=hazard ratio.
For newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
*VIALE-A was a randomized (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 [95% CI: 0.52-0.85; P<0.001]).1
†VIALE-C was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus LDAC was 7.2 months (95% CI: 5.6-10.1) vs 4.1 months for LDAC alone (95% CI: 3.1-8.8) (HR=0.75 [95% CI: 0.52-1.07; P=0.114]).1
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼
BCL-2=B-cell lymphoma 2; AZA=azacitidine; LDAC=low-dose cytarabine; CI=confidence interval; HR=hazard ratio.
VENCLYXTO + decitabine
VENCLYXTO plus DEC safety and tolerability profile
Adverse events with VENCLYXTO plus DEC were manageable and well-characterized1
- The most common treatment-emergent AEs (≥30%) were thrombocytopenia, febrile neutropenia, nausea, fatigue, pneumonia, diarrhea, neutropenia, decreased appetite, hypokalemia, dizziness (single PT), hypotension, headache, and vomiting
- Serious treatment-emergent AEs (any grade; ≥5%) were febrile neutropenia, pneumonia, bacteremia, and sepsis
- No events of laboratory or clinical TLS were reported
- Neutropenia was reported in 35% (all grades) and 35% (Grade 3 or 4) of patients
- The median duration of treatment was 5.7 months (range: 0.5–41.8 months)
DEC=decitabine; AE=adverse event; TLS tumor lysis syndrome.
[Placeholder for safety balance required by local regulations]
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.>