Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved cetuximab (14 days) in combination with FOLFIRI (14 days) for reimbursement as a treatment option for the treatment of adult patients with RAS wild type metastatic colorectal cancer. 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:
Treatment of patients with RAS wild type metastatic colorectal cancer.
Citation
Cetuximab (14 days) and FOLFIRI (14 days) Therapy, 2023, version number 5a, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/585.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | Wild type KRAS, Wild type NRAS | Colorectal Adenocarcinoma | Cetuximab, Fluorouracil, Irinotecan |