Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab (240 mg) in combination with fluoropyrimidine and platinum-based combination chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with tumor cell programmed death ligand 1 (PD-L1) expression >= 1%. This regimen specifically cites cisplatin and 5-fluorouracil as the chemotherapy.
This is written in the approval document as:
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%.
Citation
Nivolumab 240mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy, 2023, version number 1a, NCCP National SACT Regimen, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/816-nivolumab-cisplatin.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 >= 1% | Esophageal Squamous Cell Carcinoma | Cisplatin, Fluorouracil, Nivolumab |