Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab (480mg) in combination with flouropyrimidine and platinum-based 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 (OSCC) with tumor cell programmed death ligang 1 (PD-L1) expression >= 1%.

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 480mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy, 2024, version number 1a, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/832-nivolumab-cisplatin.pdf

Therapeutic 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