Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved gemcitabine (1250mg/m^2) in combination with cisplatin (75mg/m^2) (21 day) and nivolumab for reimbursement as a treatment option 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). The regimen further states that this combination is available in NCIS (00849.3).

This is written in the approval document as:

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 (00849.3)

Citation

Gemcitabine (1250mg/m2) and CISplatin (75mg/m2) Therapy - 21 day, 2024, version number 6, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/281-gemcitabine-1250mg-m2-and-cisplatin-75mg-m2-therapy-21days.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%	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Nivolumab