ERBITUX
Erbitux (cetuximab) is an epidermal growth factor receptor (EGFR) antagonist used to treat specific types of head and neck and colorectal cancers. It is indicated for squamous cell carcinoma of the head and neck in various settings, including in combination with radiation or chemotherapy and as a monotherapy. For metastatic colorectal cancer, the drug is used in patients with K-Ras wild-type, EGFR-expressing tumors or those with BRAF V600E mutations. Its therapeutic role involves targeting tumors that express EGFR, often in combination with other therapies to overcome resistance or enhance anti-tumor effects.
How ERBITUX Works
Cetuximab is a monoclonal antibody that binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells. By binding to this receptor, it competitively inhibits the binding of natural ligands, which blocks the activation of receptor-associated kinases and downstream signaling pathways. This inhibition leads to suppressed cell growth, the induction of cell death (apoptosis), and reduced production of factors involved in tumor vascularization and growth. Additionally, the drug can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types.
Details
- Status
- Prescription
- First Approved
- 2004-02-12
- Routes
- INTRAVENOUS
- Dosage Forms
- VIAL
ERBITUX Approval History
What ERBITUX Treats
4 indicationsERBITUX is approved for 4 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Head and Neck Cancer
- Squamous Cell Carcinoma of the Head and Neck
- Colorectal Cancer
- BRAF V600E Mutation-Positive Metastatic Colorectal Cancer
ERBITUX Boxed Warning
INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] . Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a ce...
WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and Administration ( 2.5 )] . Cardiopulmonary Arrest: Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration [see Warnings and Precautions ( 5.2 , 5.6 )] . WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST See full prescribing information for complete boxed warning. ERBITUX can cause serious and fatal infusion reactions. ( 5.1 , 6 ) Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 ) Cardiopulmonary arrest or sudden death occurred in patients with squamous cell carcinoma of the head and neck receiving ERBITUX with radiation therapy or with a cetuximab product with platinum-based therapy and fluorouracil. Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after ERBITUX administration. ( 5.2 , 5.6 )
ERBITUX Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
ERBITUX Competitors
Pro10 other drugs also target HER2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (HER2). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to ERBITUX
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
ERBITUX FDA Label Details
ProIndications & Usage
FDA Label (PDF)ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-a...
WARNING: INFUSION REACTIONS and CARDIOPULMONARY ARREST Infusion Reactions: ERBITUX can cause serious and fatal infusion reactions [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6 )] . Immediately interrupt and permanently discontinue ERBITUX for serious infusion reactions [see Dosage and...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.