Pembrolizumab 400mg Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

Citation

Pembrolizumab 400mg Monotherapy, 2024, version number 13, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6389/558_v12b_Pembrolizumab_400mg_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. 1
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. 1
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 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 treatment. 1
First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations Biomarkers Cancer types Therapies
HSE (1) PD-L1 (CPS) >= 1 Head and Neck Squamous Cell Carcinoma Pembrolizumab
HSE (1) dMMR Colorectal Adenocarcinoma Pembrolizumab
HSE (1) MSI-H Colorectal Adenocarcinoma Pembrolizumab
HSE (1) PD-L1 (CPS) >= 1 Cervical Adenocarcinoma Pembrolizumab
HSE (1) PD-L1 >= 50%, Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Pembrolizumab
HSE (1) PD-L1 (CPS) >= 10 Bladder Urothelial Carcinoma Pembrolizumab