ERBITUX (cetuximab)
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-02-12
- Patent Cliff
- 2013
- 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 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 ERBITUX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ERBITUX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ERBITUX
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
450 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06102902 | NCI-2023-08787 NCI-2023-08787, 2024-0120 | Ph 1 | suspended | Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer |
| NCT01810913 | NCI-2013-00500 NCI-2013-00500, RTOG-1216 | Ph 2, Ph 3 | recruiting | Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer |
| NCT06589804 | NCI-2024-07339 NCI-2024-07339, A092205 | Ph 3 | recruiting | Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment |
| NCT05063552 | NCI-2021-10021 NCI-2021-10021, EA3202 | Ph 2, Ph 3 | active not recruiting | Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers |
| NCT07042295 | NCI-2025-04318 NCI-2025-04318, SN2426 | Ph 2 | recruiting | Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System |
| NCT06806852 | 1501-0002 2024-517091-38-00 | Ph 1 | active not recruiting | A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone |
| NCT05249426 | 1443-0002 2021-003473-59 | Ph 1 | active not recruiting | A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer |
| NCT07252739 | 3475-01J U1111-1321-3999, 2025-521939-36-00 | Ph 2 | recruiting | KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J) |
| NCT07247110 | 4716-001 2025-522495-84, U1111-1323-3663 | Ph 1 | recruiting | A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) |
| NCT07209111 KANDLELIT-014 | 1084-014 MK-1084-014, U1111-1320-8626 | Ph 2 | recruiting | A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) |
| NCT04892173 | NANORAY-312 NANORAY-312, 2024-520386-31-00 | Ph 3 | recruiting | JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC |
| NCT05694936 | VADER | Ph 2 | active not recruiting | Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer |
| NCT07318805 | C6321001 2025-524387-38-00 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors |
| NCT06662786 OrigAMI-2 | 61186372COR3001 2024-513852-13-00 | Ph 3 | recruiting | A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer |
| NCT06750094 OrigAMI-3 | 61186372COR3002 2024-513853-66-00 | Ph 3 | recruiting | A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy |
| NCT05200442 | IRB21-2026 | Ph 1, Ph 2 | suspended | A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer |
| NCT07300150 | PT0511-101 | Ph 1 | recruiting | A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors |
| NCT06835569 | 3263-001 | Ph 1 | recruiting | A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations |
| NCT05355701 | C4761001 BRAF Class 2 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. |
| NCT05863195 | EA2222 NCI-2023-02357, EA2222 | Ph 3 | recruiting | Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial |
| NCT02270814 CACTUX | 201410073 | Ph 2 | active not recruiting | Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma |
| NCT05067283 KANDLELIT-001 | 1084-001 MK-1084-001, jRCT2041220034 | Ph 1 | recruiting | A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) |
| NCT07441681 | NRG-HN016 NCI-2026-00811, NRG-HN016 | Ph 3 | not yet recruiting | Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive Cisplatin |
| NCT06179160 | INCB161734-101 2023-507091-47-00 | Ph 1 | recruiting | A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation |
| NCT07535112 | 23111-1 | Ph 1 | recruiting | A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation |
| NCT05004350 NAUTICALCRC results posted | W00090GE202 | Ph 2 | completed | A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer. |
| NCT01468896 results posted | NCI-2011-03631 NCI-2011-03631, 2011C0019 | Ph 1, Ph 2 | active not recruiting | Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery |
| NCT06997497 | 1084-012 MK-1084-012, KANDLELIT-012 | Ph 3 | recruiting | A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) |
| NCT04793958 | CA239-0006 KRYSTAL-10, CA239-0006 | Ph 3 | active not recruiting | Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) |
| NCT04929223 | WO42758 2021-001207-33, 2023-505163-37-00 | Ph 1 | recruiting | A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) |
| NCT01552434 | 2012-0061 NCI-2012-00347, 2012-0061 | Ph 1 | terminated | Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease |
| NCT07549399 CRITⅡ | E2026073 | Ph 3 | not yet recruiting | SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC |
| NCT06706401 LYSARI | ET 22-156 | Ph 3 | recruiting | Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma |
| NCT07543471 PK similarity | HLX05-N-mCRC102 | Ph 1 | not yet recruiting | A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer |
| NCT05239741 | 3475-C66 MK-3475-C66 | Ph 3 | recruiting | Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66) |
| NCT01787500 | 2012-0748 NCI-2013-00541, 2012-0748 | Ph 1 | completed | Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery |
| NCT07411599 | 2025-1617 NCI-2026-00995 | Ph 1, Ph 2 | recruiting | Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC Trial") |
| NCT06720987 | KQB365-101 | Ph 1 | recruiting | A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies |
| NCT06607185 | 27237 J5Q-OX-JRDA | Ph 1 | active not recruiting | A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors |
| NCT07020221 | VS-7375-101 | Ph 1, Ph 2 | recruiting | A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors |
| NCT03389477 results posted | 201802162 | Ph 2 | active not recruiting | Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma |
| NCT05786924 | BDTX-4933-101 2025-523474-16-00 | Ph 1, Ph 2 | recruiting | Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies |
| NCT05308446 | NCI-2022-02494 NCI-2022-02494, S2107 | Ph 2 | active not recruiting | Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation |
| NCT04966481 | 202108203 | Ph 3 | recruiting | Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor |
| NCT06586515 MOONRAY-01 | 27189 J5J-OX-JZZA | Ph 1 | recruiting | MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors |
| NCT02128906 | HCC 13-056 | Ph 2 | recruiting | Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design |
| NCT05910827 | HMBD-001-103 | Ph 1, Ph 2 | recruiting | A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers |
| NCT05382559 | 3082-CL-0101 jRCT2031220738, CTR20250465 | Ph 1 | recruiting | A Study of ASP3082 in Adults With Advanced Solid Tumors |
| NCT05358249 KontRASt-03 | CJDQ443E12101 2021-006196-42 | Ph 1, Ph 2 | active not recruiting | Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation |
| NCT07223047 | CA256-0001 2025-523547-35 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies |
Showing 50 of 450 trials
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
Indications & Usage
FDA Label (PDF)ERBITUX is indicated for the treatment of Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck; Colorectal Cancer; BRAF V600E Mutation-Positive Metastatic Colorectal Cancer.
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.
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