GAZYVA
Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the treatment of specific B-cell malignancies and autoimmune disease. It is used in combination with chemotherapy for patients with previously untreated chronic lymphocytic leukemia or follicular lymphoma, and as a monotherapy for certain follicular lymphoma patients following initial combination treatment. The drug is also indicated for adult patients with active lupus nephritis who are receiving standard therapy. Its therapeutic role involves targeting B-cell populations in both oncology and autoimmune contexts.
How GAZYVA Works
Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, the drug mediates B-cell lysis by engaging immune effector cells, activating the complement cascade, and directly triggering intracellular death signaling pathways. The antibody is engineered with reduced fucose content, which enhances its affinity for immune receptors and increases its ability to induce cell death compared to rituximab. These combined mechanisms lead to the depletion of targeted B cells.
Details
- Status
- Prescription
- First Approved
- 2013-11-01
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GAZYVA Approval History
What GAZYVA Treats
3 indicationsGAZYVA is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Lymphocytic Leukemia
- Follicular Lymphoma
- Lupus Nephritis
GAZYVA Boxed 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 ...
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 )
GAZYVA Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
GAZYVA Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GAZYVA FDA Label Details
ProIndications & Usage
FDA Label (PDF)GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. 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 lymph...
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 pa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.