Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved panitumumab for reimbursement as a monotherapy treatment option for the treatment of wild-type RAS metastatic colorectal cancer (mCRC) after failure of fluoropyrimidine, oxaliplatin, and irinotecan containig chemotherapy regimens in adult patients. 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:
Treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) as monotherapy after failure of fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy regimens.
Citation
Panitumumab 6mg/kg Therapy, 2020, version number 5, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/225.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 | Panitumumab |