ERBITUX
LOE ApproachingmAbcetuximab
BLAINTRAVENOUSVIALPriority Review
Approved
Feb 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ERBITUX (cetuximab) is her1 antagonists [moa]. First approved in 2004.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERBITUX (cetuximab) is a monoclonal antibody that antagonizes the epidermal growth factor receptor (EGFR/HER1), blocking tumor cell proliferation and survival. It is administered intravenously for oncology indications including colorectal cancer and head-and-neck cancer. The drug works by binding to EGFR and preventing ligand-induced receptor activation.
$7.0MPart D
LOE ApproachingAs lifecycle approaches end-of-exclusivity, brand teams are downsizing and shifting focus to line extensions or defending market share against biosimilars and newer agents.
Mechanism of Action
HER1 Antagonists
Pharmacologic Class:
Epidermal Growth Factor Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
Started Jan 2026
267 enrolled
Colorectal Cancer Metastatic
IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Started Nov 2025
48 enrolled
Lung Cancer (Non-Small Cell)
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
Started Oct 2025
126 enrolled
Advanced Solid Tumors CancerPDACCRC (Colorectal Cancer)
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
Started Sep 2025
36 enrolled
Head and Neck NeoplasmsCarcinoma, Squamous CellNeoplasm Recurrence, Local+3 more
A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
Started Jul 2025
40 enrolled
Squamous Cell Carcinoma of Head and NeckSinus CancerNasal Cavity Cancer+9 more
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.