RAS in colorectal cancer

6 EU-approved indications in colorectal cancer need a RAS result: cetuximab (metastatic), cetuximab (1st line, metastatic), cetuximab (3rd line+, metastatic), panitumumab (1st line, metastatic), panitumumab (2nd line, metastatic) and panitumumab (3rd line+, metastatic).

Line of therapy

Approved indications, Colorectal cancer
DrugBiomarker requirementRegimenSettingConditions
RAS negative6
Cetuximab
Erbitux
RAS wild-type, EGFR-expressing
+ FOLFOX
1L
metastatic
None
Panitumumab
Vectibix
Wild-type RAS
+ FOLFOX or FOLFIRI
1L
metastatic
None
Panitumumab
Vectibix
Wild-type RAS
+ FOLFIRI
2L
metastatic
After first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)
Cetuximab
Erbitux
RAS wild-type, EGFR-expressing
Monotherapy
3L+
metastatic
Failed oxaliplatin- and irinotecan-based therapy; Intolerant to irinotecan
Panitumumab
Vectibix
Wild-type RAS
Monotherapy
3L+
metastatic
Failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens
Cetuximab
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 wording6

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.
  4. Panitumumab (Vectibix)
    in first-line in combination with FOLFOX or FOLFIRI.
  5. Panitumumab (Vectibix)
    in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  6. Panitumumab (Vectibix)
    as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.