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

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.	2
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
As monotherapy for the treatment of recurrent, or metastatic cervical cancer with disease progression on or after chemotherapy in adults whose tumours express PD-L1 with a CPS >= 1	1
First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults	2

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 50%, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
Sensitivity (+)	CD274 amplification, Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 10	Bladder Urothelial Carcinoma	Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Head and Neck Squamous Cell Carcinoma	Pembrolizumab
Sensitivity (+)	PD-L1 (CPS) >= 1	Cervical Adenocarcinoma	Pembrolizumab
Sensitivity (+)	dMMR	Colorectal Adenocarcinoma	Pembrolizumab
Sensitivity (+)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab