Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved panitumumab 6mg/kg in combination with FOLFIRI (14 day) for reimbursement as a treatment option for the second line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) who have received first-line fluoropyrimidine–based chemotherapy (excluding irinotecan). The European Medicine Agency's product information for Vectibix (panitumumab) 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 treatment of adult patients with wild-type RAS mCRC who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
Citation
Panitumumab 6mg/kg and FOLFIRI Therapy-14 day, 2023, version number 4a, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/448%20panitumumab-6mg-kg-and-folfiri-therapy-14-day.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 | Fluorouracil, Irinotecan, Panitumumab |