This is a summary of the European public assessment report (EPAR) for Erbitux. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux.
Therapeutic Indication
### Therapeutic indication 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 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.
Therapeutic Area (MeSH)
ATC Code
L01FE01
ATC Item
cetuximab
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| cetuximab | N/A | 西妥昔单抗 |
EMA Name
Erbitux
Medicine Name
Erbitux
Aliases
N/ANo risk management plan link.
