Drug updated on 10/30/2024
| Dosage Form | Tablet (oral; 10 mg, 50 mg, 100 mg) |
| Drug Class | BCL-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.
Latest News
Summary
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Chronic Lymphocytic Leukemia (CLL): Venetoclax combined with obinutuzumab significantly improved progression-free survival (PFS) and overall survival (OS) over chemoimmunotherapy; however, while it was cost-effective, acalabrutinib-obinutuzumab combinations had higher life-years (LYs) and quality-adjusted life-years (QALYs).
- Acute Myeloid Leukemia (AML): Venetoclax combined with azacitidine, decitabine, or low-dose cytarabine enhanced complete remission (CR) and OS in newly diagnosed AML patients, especially those older or unsuitable for intensive chemotherapy, with a pooled CR/CRi rate of 57.9% in AML and MDS.
- TP53-Mutated AML: Venetoclax with hypomethylating agents (HMAs) achieved a CR rate of 33% and median OS of 6.2 months, indicating moderate effectiveness but limited survival outcomes across available treatments.
- Relapsed/Refractory CLL: Venetoclax with anti-CD20 antibodies achieved high response rates with a pooled ORR of 82% and undetectable minimal residual disease (uMRD) rates of 89% in venetoclax + anti-CD20 and 57% in venetoclax + ibrutinib combinations.
- Chronic Lymphocytic Leukemia (CLL): Venetoclax-obinutuzumab had a favorable safety profile with lower incidences of serious adverse events (AEs) grade 1-5 compared to chemoimmunotherapy, particularly reducing cardiovascular, gastrointestinal, and infectious AEs.
- Acute Myeloid Leukemia (AML): Venetoclax combined with azacitidine or low-dose cytarabine showed increased rates of febrile neutropenia and gastrointestinal toxicity, with a notable incidence of grade 3-4 neutropenia at 53.7% in the venetoclax + azacitidine regimen, highlighting a significant safety concern.
- Comparative Safety in CLL and AML: Venetoclax-obinutuzumab in CLL displayed a comparable safety profile to zanubrutinib and BTKi monotherapies but had higher risks of hematological AEs in combination therapies, while venetoclax combinations in AML resulted in elevated febrile neutropenia and gastrointestinal AEs relative to azacitidine and decitabine monotherapies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Venclexta (venetoclax) Prescribing Information. | 2024 | AbbVie Inc., North Chicago, IL |