Drug updated on 4/24/2024
| Dosage Form | Injection (intravenous; 1,000 mg/40 mL [25 mg/mL]) |
| Drug Class | CD20-directed cytolytic antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia.
- Indicated in combination with bendamustine followed by gazyva monotherapy, for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen.
- Indicated in combination with chemotherapy followed by gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.
Summary
- Obinutuzumab (Gazyva) is recommended for the management of individuals with previously untreated chronic lymphocytic leukemia in combination with chlorambucil, and for patients with follicular lymphoma who have relapsed after, or are refractory to, a rituximab-containing regimen. The drug is also advised in combination with chemotherapy followed by Gazyva monotherapy for patients achieving at least a partial remission, specifically targeting adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma.
- The data on this medication was analyzed from eight systematic reviews/meta-analyses. These reviews offer in-depth analyses on its efficacy and safety across various conditions including chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL).
- Regarding efficacy among FL patients, Obinutuzumab significantly improves progression-free survival compared to observation alone but does not offer an overall survival advantage. It also exhibits higher toxicity compared to extended courses of rituximab, which likewise demonstrate progression-free survival benefits.
- In CLL treatment settings, aside from scenarios involving del17/P53 mutation where it is nearly comparable to the aCD20 mAbs/Ibrutinib combination, regimens containing Obinutuzumab lead in effectiveness. Monotherapies, such as Acalabrutinib alone, present better safety profiles.
- Comparing Obinutuzumab with other anti-CD20 monoclonal antibodies, such as Ocrelizumab, demonstrates promising outcomes but comes with an increased risk of serious infections. This suggests that its use should be carefully considered due to its safety profile.
- Elderly patient groups may receive significant advantages from novel agents such as Obinutuzumab over traditional cytotoxic therapies, thanks to improved outcomes and tolerable toxicity profiles. This indicates more tailored treatment regimens based on individual patient characteristics, including age and specific biological markers of disease.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gazyva (obinutuzumab) Prescribing Information. | 2022 | Genentech Inc., South San Francisco, CA |