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Gazyva (obinutuzumab)
Gazyva binds to the CD20 antigen on B-lymphocytes, triggering their destruction.
Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody developed by Genentech, targeting B-lymphocytes in patients with CD20-positive follicular lymphoma and chronic lymphocytic leukemia. It works by binding to the CD20 antigen on the surface of cancer cells, marking them for destruction. Gazyva is a patented medication, approved by the FDA in 2013, and is used in combination with other treatments. Key safety considerations include infusion reactions, infections, and cytopenias. As a small molecule modality, Gazyva is a targeted therapy that selectively targets cancer cells.
At a glance
| Generic name | obinutuzumab |
|---|---|
| Sponsor | Roche |
| Drug class | CD20-directed Cytolytic Antibody [EPC] |
| Target | B-lymphocyte antigen CD20 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 1200 |
Mechanism of action
Obinutuzumab is monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature lymphocytes. Upon binding to CD20, obinutuzumab mediates B-cell lysis through (1) engagement of immune effector cells, (2) by directly activating intracellular death signaling pathways (direct cell death), and/or (3) activation of the complement cascade. The immune effector cell mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis.As an antibody with reduced fucose content, obinutuzumab induces greater ADCC activity than rituximab in vitro using human cancer cell lines. Obinutuzumab also demonstrated an increased ability to induce direct cell death when compared to rituximab. Obinutuzumab binds to FcRIII using purified proteins with higher affinity than rituximab. Obinutuzumab and rituximab bind with similar affinity to overlapping epitopes on CD20.
Approved indications
- CD20-positive follicular lymphoma
- Chronic lymphoid leukemia, disease
Boxed warnings
- WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.1) ] . Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA [see Warnings and Precautions (5.2) ] . WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.2 )
Common side effects
- Neutropenia
- COVID-19
- Myelosuppression
- Infusion related reaction
- Tumour lysis syndrome
- Thrombocytopenia
- Disease progression
- Cytokine release syndrome
- Pyrexia
- Chills
- Neutrophil count decreased
- Atrial fibrillation
Key clinical trials
- A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) (PHASE3)
- CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) (PHASE3)
- A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) (PHASE3)
- A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma (PHASE1)
- Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (PHASE2)
- Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia (PHASE3)
- Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma (PHASE1,PHASE2)
- Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gazyva CI brief — competitive landscape report
- Gazyva updates RSS · CI watch RSS
- Roche portfolio CI