KEY DATA
PBS listed:
VENCLEXTA in combination with azacitidine is PBS listed for treatment of acute myeloid leukaemia (AML).1
In VIALE-A, the phase 3 randomised, double-blind, placebo-controlled, trial that compared VENCLEXTA + azacitidine (N=286) vs azacitidine + placebo (N=145) in adult patients with newly diagnosed AML who were ineligible for intensive chemotherapy, at a median follow-up of 20.5 months:2,3
Longer Median Overall Survival*2,3
*5.1-month increase in median overall survival with VEN+AZA vs AZA + placebo (14.7 months vs 9.6 months, HR 0.66, 95% Cl: 0.52–0.85, p<0.001, dual primary endpoint).2,3
More Remissions (CR+CRi)†2,3
†VEN+AZA more than DOUBLED the remission rate (CR+CRi) vs AZA + placebo (66% vs 28%, p<0.001, dual primary endpoint).2,3
More Transfusion Independence§
§Transfusion independence^ was achieved in 60% (RBC) and 69% (platelet) of patients receiving VEN+AZA vs 35% (RBC) and 50% (platelet) for AZA + placebo (p<0.001).2,3
^Transfusion independence was defined as a period of at least 56 consecutive days with no transfusion after the first dose of study drug and on or before the last dose of the study drug plus 30 days, or before relapse or disease progression or before the initiation of post treatment therapy, whichever is earlier.2
VEN+AZA Safety Profile:
The most common grade ≥3 adverse reactions (incidence ≥20% and ≥2% higher than AZA + placebo) were thrombocytopenia (48%), neutropenia (45%), febrile neutropenia (42%), and anaemia (26%).2 Neutropenia, serious infections and TLS are identified risks associated with VENCLEXTA treatment.2 Refer to the full Product Information for prophylaxis and monitoring recommendations, or visit the SAFETY section for more information.
DOWNLOADABLE RESOURCES
Treatment guide for VENCLEXTA + azacitidine (AML)
A practical guide to initiating and managing treatment with VENCLEXTA + azacitidine for patients with AML.
Patient information brochure for VENCLEXTA + azacitidine treatment (AML)
Share this resource with your AML patients to help support them during VENCLEXTA + azacitidine treatment.
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PBS Information
Venclexta: VENCLEXTA (venetoclax) in combination with rituximab is PBS listed for relapsed or refractory chronic lymphocytic leukaemia (CLL). VENCLEXTA in combination with obinutuzumab is PBS listed for first line treatment of CLL or small lymphocytic lymphoma (SLL). VENCLEXTA in combination with azacitidine is PBS listed for treatment of acute myeloid leukaemia (AML). General Schedule listing. Authority required (telephone). Refer to PBS schedule for full authority information. VENCLEXTA monotherapy is not listed on the PBS. VENCLEXTA in combination with low-dose cytarabine is not listed on the PBS for treatment of AML.
Please review the full Product Information (PI) before prescribing, available below.
1L: first-line. AML: acute myeloid leukaemia. AZA: azacitidine. CI: confidence interval. CLL: chronic lymphoytic leukaemia. CR: complete remission. CRi: complete remission with incomplete haematological recovery. HR: hazard ratio. ITT: intention-to-treat. R/R CLL: relapsed or refractory CLL. TLS: tumour lysis syndrome. V: VENCLEXTA. VEN: VENCLEXTA.
References: 1. Australian Government Department of Health. Schedule of Pharmaceutical Benefits, www.pbs.gov.au. Accessed December 2021. 2. VENCLEXTA Product Information. 3. DiNardo CD et al. N Engl J Med 2020; 383(7): 617–29.
AU-VENA-210064 Last revised September 2022