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
VENCLYXTO IS THE FIRST APPROVED BCL-2
INHIBITOR FOR THE TREATMENT OF AML1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2 INHIBITOR FOR THE TREATMENT OF AML1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2 INHIBITOR FOR THE TREATMENT OF AML1
Study M14-358 was a nonrandomised Phase 1/2 clinical trial of VENCLYXTO in combination with azacitidine (n=84) or decitabine (DEC) (n=31) in newly diagnosed patients with AML who were ineligible for intensive chemotherapy. VENCLYXTO + DEC demonstrated a 74% remission rate (CR+CRi) (95% CI: 55-88).1
SAFETY/TOLERABILITY FOR VENCLYXTO + DECITABINE
DISCONTINUATION RATES WITH VENCLYXTO PLUS DEC
DISCONTINUATIONS, DOSE INTERRUPTIONS, AND DOSE REDUCTIONS DUE TO ARs FOR VEN+DEC1
| • | 26% of patients discontinued treatment |
| • | 65% of patients experienced dose interruption |
| • | 6% of patients had dose reductions |
| • | The most common ARs that led to dose interruptions (≥5%) were febrile neutropaenia, neutropaenia/decreased neutrophil count, pneumonia, decreased platelet count, and decreased white blood cell count |
ADVERSE REACTIONS WITH VENCLYXTO PLUS DEC WERE MANAGEABLE AND WELL-CHARACTERISED1
| • | The most commonly occurring ARs (≥20%) of any grade in patients receiving VENCLYXTO plus DEC were thrombocytopaenia, febrile neutropaenia, nausea, haemorrhage, pneumonia, diarrhoea, fatigue, dizziness/syncope, vomiting, neutropaenia, hypotension, hypokalaemia, decreased appetite, headache, abdominal pain, and anaemia |
| • | Most frequently reported serious ARs (≥5%) were febrile neutropaenia, pneumonia, bacteraemia, and sepsis |
| • | No events of laboratory or clinical TLS were reported |
| • | Neutropaenia was reported in 35% (all grades) and 35% (Grade 3 or 4) of patients |
VENCLYXTO ADVERSE DRUG REACTIONS
DEMONSTRATED IN PATIENTS WITH AML1
*Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).1
†Only the highest frequency observed in the trials is reported (based on studies VIALE-A and M14-358).
‡Includes multiple adverse reaction terms.
AML=acute myeloid leukaemia; AR=adverse reaction; BCL-2=B-cell lymphoma 2; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DEC=decitabine; TLS=tumour lysis syndrome; VEN=VENCLYXTO.
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. December 2022.
ALL-VNCAML-220066 October 2023