Cetuximab

Cetuximab (Erbitux, Merck Europe B.V. ) has 7 EU-approved indications in 2 tumour types. 2 need a biomarker result: BRAF (2).
Approved indications of Cetuximab
Biomarker requirementRegimenSettingConditions
Colorectal cancer5
BRAF V600E
+ encorafenib and FOLFOX
1L
metastatic
None
RAS wild-type, EGFR-expressing
+ FOLFOX
1L
metastatic
None
BRAF V600E
+ encorafenib
2L
metastatic
After prior systemic therapy
RAS wild-type, EGFR-expressing
Monotherapy
3L+
metastatic
Failed oxaliplatin- and irinotecan-based therapy; Intolerant to irinotecan
RAS wild-type, EGFR-expressing
+ irinotecan-based chemotherapy
Any line
metastatic
None
Head and neck squamous cell carcinoma2
None
+ platinum-based chemotherapy
Any line
advanced
None
None
+ radiation therapy
Any line
locally adv.
None
Full text of section 4.1 (therapeutic 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.

Label history

43 changes to the Erbitux label since 2005, 8 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes