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 (00849.1)

This is written in the approval document.

Reimbursement

Incomplete Reimbursement

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

Citation

CARBOplatin (AUC 6) and PACLitaxel 200mg/m2 Therapy, 2020, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6924/304_V8_CARBOplatinAUC_6_PACLitaxel_200.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, Nivolumab, Paclitaxel

Contributions

Date	Contributor	Description
2024-05-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database