← Drug database

Erbitux (cetuximab)

Region

🇪🇺 EU

Active substance

cetuximab

Company

Merck Europe B.V.

Status

Authorised

Therapeutic area

Head and Neck Neoplasms; Colorectal Neoplasms

EU approval

Tue 29 Jun 2004

Application

EMEA/H/C/000558

ATC

L01FE01

Official record

www.ema.europa.eu

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 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.

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.