Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR positive, Wild type KRAS, Wild type NRAS status confers therapeutic sensitivity to Cetuximab in patients with Colorectal Adenocarcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved cetuximab (7 day) for reimbursement as a monotherapy treatment option for the treatment of epidermal growth factor (EGFR)-expressing RAS wild-type metastatic colorectal cancer (mCRC) which has failed oxaliplatin- and irinotecan-based therapy that is intolerant to irinotecan in adult patients. The European Medicine Agency's product information for Erbitux (cetuximab) defines RAS wild type as considering mutational status of KRAS and NRAS exons 2, 3, and 4, and that mutational status should be determined by an experienced laboratory using validated test methods.
This statement is based on a regulatory approval from the Health Service Executive:
As monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer (mCRC) in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.