Drug updated on 4/26/2024
| 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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Venclexta (venetoclax) prescribing information. | 2022 | AbbVie Inc., North Chicago, IL |