Regulatory approval
Published by the Health Service Executive.
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 is written in the approval document as:
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.
Citation
Cetuximab Therapy-7 day, 2020, version number 4, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/207.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR positive, Wild type KRAS, Wild type NRAS | Colorectal Adenocarcinoma | Cetuximab |