ZEVALIN (ibritumomab tiuxetan)
ZEVALIN is indicated for the treatment of Non-Hodgkin's Lymphoma.
How ZEVALIN Works
Ibritumomab tiuxetan targets the CD20 antigen, a protein expressed on the surface of more than 90% of B-cell non-Hodgkin’s lymphomas and mature B lymphocytes. The antibody is covalently linked to a chelate that binds the radioisotope Y-90, which delivers beta radiation to the site of the tumor. This beta emission induces cellular damage by forming free radicals within the target cells and neighboring cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-02-19
- Patent Cliff
- 2009
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZEVALIN Approval History
What ZEVALIN Treats
1 indicationsZEVALIN is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Hodgkin's Lymphoma
ZEVALIN Boxed Warning
SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion ...
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion [ see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ] . Discontinue rituximab and Y-90 Zevalin infusions in patients who develop severe infusion reactions. Prolonged and Severe Cytopenias: Y-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 Zevalin to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 ) ]. Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen. Discontinue rituximab and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ]. Dosing: The dose of Y-90 Zevalin should not exceed 32 mCi (1184 MBq) [ see Dosage and Administration ( 2.2 ) ]. WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS See full prescribing information for complete boxed warning Serious Infusion Reactions, some fatal, may occur within 24 hours of rituximab infusion. ( 5.1 ) Prolonged and Severe Cytopenias occur in most patients. ( 5.2 ) Severe Cutaneous and Mucocutaneous Reactions, some fatal, reported with Zevalin therapeutic regimen. ( 5.3 , 6.2 ) Do not exceed 32 mCi (1184 MBq) of Y-90 Zevalin. ( 2.2 )
ZEVALIN 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.
ZEVALIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZEVALIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZEVALIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZEVALIN
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01510184 results posted | SPI-ZEV-11-301 | Ph 3 | terminated | Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy |
| NCT01662102 results posted | SPI-ZEV-12-302 | Ph 3 | terminated | Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta) |
| NCT00662948 | ZAR2007 | Ph 2 | completed | ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®) |
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.
ZEVALIN FDA Label Details
Indications & Usage
FDA Label (PDF)ZEVALIN is indicated for the treatment of Non-Hodgkin's Lymphoma.
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated w...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment