Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved cetuximab (7 days) in combination with irinotecan (14 days) for reimbursement as a treatment option for the second line treatment of adult patients with metastatic colorectal cancer with non-mutated (wild type) RAS after failure of or contraindication to oxaliplatin based therapy. 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:

Second line therapy for metastatic colorectal cancer with non-mutated (wild type) RAS after failure of or contraindication to oxaliplatin based therapy.

Citation

Cetuximab (14 days) and Irinotecan (14 days) Therapy, 2022, version number 6, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/331-cetuximab-14-days-and-irinotecan-14-days-therapy-.pdf

Therapeutic 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, Irinotecan