Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of adult patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors have PD-L1 expression >= 1%. The treatment regimen contians five treatment schedules: (1) nivolumab 360 mg, CARBOplatin (AUC6), and PAClitaxel (200 mg/m^2); (2) nivolumab 360mg, gemcitabine (1000 mg/m^2), and CARBOplatin (AUC5); (3) nivolumab 360 mg, gemcitabine 1250 mg/m^2, and CISplatin 75 mg/m^2; (4) nivolumab 360 mg, PEMEtrexed, and CARBOplatin with folic acid or multivtamin containig 350-1000 micrograms of folic acid; and (5) nivolumab 360 mg, PEMEtrexed, and CISplatin along with folic acid or multivitamin containig 350-1000 mg of folic acid.

This is written in the approval document as:

Nivolumab in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression >= 1%.

Citation

Nivolumab 360mg and Chemotherapy, 2024, version number 1, NCCP National SACT Regimen, NCCP, viewed 19/06/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/849-nivolumab-360mg-and-chemotherapy.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	Carboplatin, Nivolumab, Paclitaxel
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Gemcitabine, Nivolumab
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Nivolumab
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Pemetrexed
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Nivolumab, Pemetrexed