Pembrolizumab 200mg Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

Citation

Pembrolizumab 200mg Monotherapy, 2026, version number 16, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6903/455_V15b__Pembrolizumab_200mg_Monotherapy.pdf

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
First-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a >= 50% tumour proportion score (TPS) with no EGFR mutations or ALK translocations.
As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) >= 10.
As monotherapy for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS >= 1
For the maintenance treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 with a CPS >= 1 who have completed the induction chemotherapy component of the treatment.
First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies