Drug updated on 11/1/2024
| 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.
Latest News
Summary
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- The studies focused on chronic lymphocytic leukemia (CLL) patients with advanced age and/or comorbidities, including high-risk genetic subgroups such as TP53 aberrations, IGHV unmutated status, and 11q deletion, with findings indicating that patients with unmutated IGHV status had better progression-free survival (PFS) with acalabrutinib plus obinutuzumab compared to venetoclax plus obinutuzumab.
- In patients with B-cell non-Hodgkin lymphomas (B-NHL), the studies included those with CD20-positive B-NHL, showing that obinutuzumab significantly improved PFS but had a higher incidence of adverse events compared to rituximab.
- Zanubrutinib was identified as the safest treatment option for chronic lymphocytic leukemia (CLL) patients with advanced age and/or comorbidities, followed by venetoclax-obinutuzumab, while Bruton's tyrosine kinase inhibitor (BTKi) monotherapies demonstrated more favorable safety profiles regarding hematological adverse events (AEs).
- Obinutuzumab was associated with increased incidences of serious AEs, including an odds ratio (OR) of 1.29 for serious AEs, a relative risk (RR) of 2.8 for thrombocytopenia, infusion-related reactions, and a RR of 1.65 for cardiac events compared to rituximab, indicating higher toxicity in obinutuzumab-based regimens.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gazyva (obinutuzumab) Prescribing Information. | 2022 | Genentech, Inc., South San Francisco, CA |