Cetuximab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2004
- First approval year
- 2004
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Cetuximab
- erbitux
- Erbitux
- abp 494
- ABP-494
- becotatug cetuximab
- bevacizumab cetuximab
- c 225
- C-225
- c225
- C225
- C225 (cetuximab)
- cetuximab
- Cetuximab
- CETUXIMAB
- cetuximab (Cohort C2 Only)
- Cetuximab (CRC)
- Cetuximab (EGFR inhibitor)
- cetuximab (Erbitux ®)
- cetuximab (Erbitux)
- Cetuximab (Erbitux)
- Cetuximab (ERBITUX)
- cetuximab (Erbitux®)
- Cetuximab (genetical recombination)
- CETUXIMAB (GENETICAL RECOMBINATION) [JAN]
- Cetuximab (SCCHN)
- CETUXIMAB [EMA EPAR]
- CETUXIMAB [HSDB]
And 67 more, listed on the interactive page.
- ATC classification codes
- L01FE01
Sources for recorded values
- CAS registry numbers
- 205923-56-4
- ChEMBL ID
- CHEMBL1201577
- RxNorm IDs (RxCUI)
- 318341
- FDA ingredient codes (UNII)
- PQX0D8J21J
- Applicant
- IMCLONE
- Approval date
- 12 Feb 2004
- Application number
- BLA125084
- Status
- Authorised
- Status date
- 29 Jun 2004
- Authorisation date
- 29 Jun 2004
- Approved indications
- Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer: in combination with encorafenib and FOLFOX for the first line treatment; in combination with encorafenib in patients who have received prior systemic therapy. For details, see section 5.1, for biomarker-based patient selection, see section 4.2. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck: in combination with radiation therapy for locally advanced disease; in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
- Product number
- EMEA/H/C/000558
- Authorisation holder
- Merck Europe B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Colorectal Neoplasms
- Head and Neck Neoplasms
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 1 Mar 2013
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- cetuximab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- epidermal growth factor receptor
- Gene symbol
- EGFR
- Protein identifier
- P00533
- Median affinity
- 9.41
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Epidermal growth factor receptor erbB1 inhibitor
- Action type
- Inhibitor
- Target
- Epidermal growth factor receptor
- Protein identifier
- P00533
Open Targets mechanisms
- Mechanism
- Epidermal growth factor receptor erbB1 inhibitor
- Action type
- Inhibitor
- Target
- Epidermal growth factor receptor
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Carcinoma, Adenoid Cystic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000231
- Subject identifier
- D003528
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000708
- Subject identifier
- D002294
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001061
- Subject identifier
- D002583
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Astrocytoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002499
- Subject identifier
- D001254
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002916
- Subject identifier
- D004938
- Condition
- Hypopharyngeal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002938
- Subject identifier
- D007012
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Laryngeal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003817
- Subject identifier
- D007822
- Condition
- Anus Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003835
- Subject identifier
- D001005
- Condition
- Mouth Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003868
- Subject identifier
- D009062
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
And 55 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000228
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000231
- Condition identifier
- EFO_0000365
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000571
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000707
- Condition identifier
- EFO_0001061
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002916
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002938
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003868
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003897
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004142
- Condition identifier
- EFO_0004198
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005762
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005922
- Highest recorded phase
- 2
And 128 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Event
- anaphylactic reaction
- Reports
- 242
- Reporting signal score
- 191.14
- Event
- arthralgia
- Reports
- 30
- Reporting signal score
- 128.629
- Event
- dehydration
- Reports
- 469
- Reporting signal score
- 393.883
- Event
- dermatitis acneiform
- Reports
- 392
- Reporting signal score
- 1,353.84
- Event
- diarrhoea
- Reports
- 831
- Reporting signal score
- 209.378
- Event
- dysphagia
- Reports
- 259
- Reporting signal score
- 163.23
- Event
- febrile neutropenia
- Reports
- 242
- Reporting signal score
- 170.352
- Event
- hypomagnesaemia
- Reports
- 262
- Reporting signal score
- 537.08
- Event
- infusion related reaction
- Reports
- 479
- Reporting signal score
- 668.316
- Event
- injection site pain
- Reports
- 1
- Reporting signal score
- 138.599
- Event
- leukopenia
- Reports
- 247
- Reporting signal score
- 204.903
- Event
- malignant neoplasm progression
- Reports
- 204
- Reporting signal score
- 140.042
- Event
- mucosal inflammation
- Reports
- 416
- Reporting signal score
- 784.394
- Event
- neutropenia
- Reports
- 605
- Reporting signal score
- 501.978
- Event
- palmar-plantar erythrodysaesthesia syndrome
- Reports
- 135
- Reporting signal score
- 138.995
- Event
- paronychia
- Reports
- 124
- Reporting signal score
- 309.429
- Event
- pyrexia
- Reports
- 544
- Reporting signal score
- 139.127
- Event
- radiation skin injury
- Reports
- 83
- Reporting signal score
- 280.408
- Event
- rash
- Reports
- 836
- Reporting signal score
- 380.245
- Event
- skin toxicity
- Reports
- 159
- Reporting signal score
- 391.356
- Event
- stomatitis
- Reports
- 275
- Reporting signal score
- 302.691
- NCT00003809
- NCT00004227
- NCT00004865
- NCT00005814
- NCT00084318
- NCT00089297
- NCT00096174
- NCT00122460
- NCT00265941
- NCT00291707
- NCT00301028
- NCT00319839
- NCT00468169
- NCT00524017
- NCT00629226
- NCT00646659
- NCT00665392
- NCT00704639
- NCT00714649
- NCT00721513
- NCT00738868
- NCT00765011
- NCT00791141
- NCT00833261
- NCT00851877
And 536 more, listed on the interactive page.
- Dose
- 400 mg/m2 initial dose; 250 mg/m2 subsequent doses; 500 mg/m2 every 2 weeks
- Route
- Intravenous
- How often
- Weekly or biweekly
- Administer as infusion over 60-120 minutes
- Complete administration 1 hour prior to radiation therapy or other treatments
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- DILLTQSPVILSVSPGERVSFSCRASQSIGTNIHWYQQRTNGSPRLLIKYASESISGIPSRFSGSGSGTDFTLSINSVESEDIADYYCQQNNNWPTTFGAGTKLELKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGA
- Component
- Sequence
- Type
- Protein
- Sequence
- QVQLKQSGPGLVQPSQSLSITCTVSGFSLTNYGVHWVRQSPGKGLEWLGVIWSGGNTDYNTPFTSRLSINKDNSKSQVFFKMNSLQSNDTAIYYCARALTYYDYEFAYWGQGTLVTVSAASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 66733-948
- 66733-958
Related records
Trials (978)
- 3'-Deoxy-3'-[18F] Fluorothymidine and Fludeoxyglucose F 18 PET Scans in Evaluating Response to Cetuximab, Cisplatin, and Radiation Therapy in Patients With Advanced Cancer of the Oropharynx, Larynx, or Hypopharynx
- 5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC)
- A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
- A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
- A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
- A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
- A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
- A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
- A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
- A First-in-Human Study Investigating BG-85738 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors With Rat Sarcoma Virus (RAS) Mutations
- A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification
- A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
- A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment
- A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
- A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
- A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
- A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
- A Phase 1b Study of WU-NK-101 in Combination With Cetuximab
- A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
Approved for (14)
- Cancer
- Colorectal adenocarcinoma
- Colorectal cancer
- Colorectal carcinoma
- Colorectal neoplasm
- Head and neck cancer
- Head and neck carcinoma
- Head and neck neoplasm
- Head and neck squamous cell carcinoma
- Malignant tumor of neck
- Neoplasm
- Squamous cell carcinoma
- Squamous cell lung carcinoma
- Upper aerodigestive tract neoplasm
In development for (65)
- Adenocarcinoma Phase 2
- Adenoid cystic carcinoma Phase 1
- Anaplastic astrocytoma Phase 1
- Anus cancer Phase 2
- Anus neoplasm Phase 2
- Bile duct carcinoma Phase 2
- Biliary tract neoplasm Phase 2
- Brain cancer Phase 1
- Breast cancer Phase 2
- Breast neoplasm Phase 2
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 3
- Cervical cancer Phase 2
- Cervical carcinoma Phase 2
- Cholangiocarcinoma Phase 2
- Chordoma Phase 2
- Colon adenocarcinoma Phase 2
- Colon carcinoma Phase 3
- Colonic neoplasm Phase 3
- Complex regional pain syndrome Phase 2
Other linked conditions (1)
- Squamous cell neoplasm
Targets (1)
- EGFR Epidermal growth factor receptor erbB1 inhibitor