EGFR in colorectal cancer

3 EU-approved indications in colorectal cancer need a EGFR result: cetuximab (metastatic), cetuximab (1st line, metastatic) and cetuximab (3rd line+, metastatic).

Line of therapy

Approved indications, Colorectal cancer
DrugBiomarker requirementRegimenSettingConditions
EGFR3
Erbitux
RAS wild-type, EGFR-expressing
+ FOLFOX
1L
metastatic
None
Erbitux
RAS wild-type, EGFR-expressing
Monotherapy
3L+
metastatic
Failed oxaliplatin- and irinotecan-based therapy; Intolerant to irinotecan
Erbitux
RAS wild-type, EGFR-expressing
+ irinotecan-based chemotherapy
Any line
metastatic
None

5 approvals for CRC need no biomarker and apply whatever the result. All approvals for CRC

See also

Label wording3

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Cetuximab (Erbitux)
    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,
  2. Cetuximab (Erbitux)
    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,
  3. Cetuximab (Erbitux)
    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.