Venetoclax

(Venclexta®)

Venetoclax

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Drug updated on 4/26/2024

Dosage FormTablet (oral; 10 mg, 50 mg, 100 mg)
Drug ClassBCL-2 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Indicated in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Summary
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  • Venetoclax (Venclexta) is approved for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, and in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia in adults who are 75 years or older, or have comorbidities that preclude intensive induction chemotherapy.
  • Nine studies were reviewed to gather information about Venetoclax.
  • In the management of multiple myeloma, Venetoclax has shown meaningful effects, especially when included in multi-drug regimens targeting specific genetic profiles in relapsed/refractory populations.
  • For acute myeloid leukemia patients not eligible for intensive chemotherapy, Venetoclax combined with hypomethylating agents has emerged as a standard of care. However, real-world evidence suggests a lower median survival compared to clinical trial data, emphasizing the importance of personalized treatment approaches.
  • Compared to other novel drugs used for relapsed/refractory multiple myeloma treatment, such as carfilzomib and daratumumab, Venetoclax demonstrated lower overall response rates but remained a viable option, particularly in certain patient subgroups, highlighting the need for targeted therapy based on the individual's profile.
  • Venetoclax displayed manageable adverse events across various hematologic malignancies including chronic lymphocytic leukemia/small lymphocytic lymphoma and acute myeloid leukemia, often presenting a more favorable risk-benefit ratio when tailored according to disease attributes. It requires careful monitoring due to its frequent hematologically natured side-effects like neutropenia.

Product Monograph / Prescribing Information

Document TitleYearSource
Venclexta (venetoclax) prescribing information.2022AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of Venetoclax-based regimens in relapsed or refractory multiple myeloma: a systematic review and meta-analysis of prospective clinical trials.2023Annals of Medicine
Venetoclax with Hypomethylating Agents in Newly Diagnosed Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis of Survival Data from Real-World Studies. 2023Cancers
Comparative efficacy of novel-drugs combined therapeutic regimens on relapsed/refractory multiple myeloma: a network meta-analysis. 2023Hematology
Therapies for acute myeloid leukemia in patients ineligible for standard induction chemotherapy: a systematic review. 2023Future Oncology
The efficacy and safety of venetoclax and azacytidine combination treatment in patients with acute myeloid leukemia and myelodysplastic syndrome: systematic review and meta-analysis. 2023Hematology
The efficacy and adverse events of venetoclax in combination with hypomethylating agents treatment for patients with acute myeloid leukemia and myelodysplastic syndrome: a systematic review and meta-analysis.2020Hematology
Comparative efficacy of acalabrutinib in frontline treatment of chronic lymphocytic leukemia: a systematic review and network meta-analysis.2020Clinical Therapeutics
Efficacy and safety of BCL-2 inhibitor venetoclax in hematological malignancy: a systematic review and meta-analysis of clinical trials.2019Frontiers in Pharmacology
Treatment outcomes of novel targeted agents in relapse/refractory chronic lymphocytic leukemia: a systematic review and network meta-analysis.2019Journal of Clinical Medicine

Clinical Practice Guidelines