BRAF in colorectal cancer

4 EU-approved indications in colorectal cancer need a BRAF result: encorafenib (2nd line, metastatic), encorafenib (1st line, metastatic), cetuximab (1st line, metastatic) and cetuximab (2nd line, metastatic).

Line of therapy

Approved indications, Colorectal cancer
DrugBiomarker requirementRegimenSettingConditions
BRAF mutation4
Cetuximab
Erbitux
V600E
+ encorafenib and FOLFOX
1L
metastatic
None
Encorafenib
Braftovi
V600E
+ cetuximab and FOLFOX
1L
metastatic
None
Cetuximab
Erbitux
V600E
+ encorafenib
2L
metastatic
After prior systemic therapy
Encorafenib
Braftovi
V600E
+ cetuximab
2L
metastatic
After prior systemic therapy

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

See also

Label wording4

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

  1. Encorafenib (Braftovi)
    Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, who have received prior systemic therapy.
  2. Encorafenib (Braftovi)
    Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.
  3. Cetuximab (Erbitux)
    • in combination with encorafenib and FOLFOX for the first line treatment.
  4. Cetuximab (Erbitux)
    • in combination with encorafenib in patients who have received prior systemic therapy.