Regulatory approval

Published by the Health Service Executive. Approved

In combination with nivolumab for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1% (3 cycles only). This combination is available in NCIS (00849.2)

This is written in the approval document.

Reimbursement

Incomplete Reimbursement

Nivolumab - ODMS 2024-05-01; Chemotherapy - N/A

Citation

Gemcitabine (1000mg/m2) and CARBOplatin (AUC 5) Therapy - 21 day, 2025, version number 7, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6713/310_v7_GemCARBOAUC_5.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Gemcitabine, Nivolumab