Obinutuzumab

(Gazyva®)

Obinutuzumab

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 1,000 mg/40 mL [25 mg/mL])
Drug ClassCD20-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

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Summary
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  • 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 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 TitleYearSource
Gazyva (obinutuzumab) Prescribing Information.2022Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety profile of first-line targeted therapies in elderly and/or comorbid chronic lymphocytic leukaemia patients (unfit subpopulation). A systematic review and network meta-analysis2024Critical Reviews in Oncology/Hematology
Molecular-Biology-Driven Frontline Treatment for Chronic Lymphocytic Leukemia: A Network Meta-Analysis of Randomized Clinical Trials2023International Journal of Molecular Sciences
Efficacy of front-line immunochemotherapy for follicular lymphoma: a network meta-analysis of randomized controlled trials2022Blood Cancer Journal
Comparison Between Venetoclax-based and Bruton Tyrosine Kinase Inhibitor-based Therapy as Upfront Treatment of Chronic Lymphocytic Leukemia (CLL): A Systematic Review and Network Meta-analysis2021Clinical Lymphoma, Myeloma & Leukemia
Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20(+) B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis2021Scientific Reports
Obinutuzumab-related adverse events: A systematic review and meta-analysis2021Hematological Oncology
Treatment of hairy cell leukemia2020Expert Review of Hematology
Novel Targeted Therapies for Chronic Lymphocytic Leukemia in Elderly Patients: A Systematic Review2020Clinical Lymphoma, Myeloma & Leukemia
Comparison of acalabrutinib plus obinutuzumab, ibrutinib plus obinutuzumab and venetoclax plus obinutuzumab for untreated CLL: a network meta-analysis2020Critical Reviews In Oncology/Hematology

Clinical Practice Guidelines