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

Regulatory approval published by the Health Service Executive.

Citation

Pembrolizumab 400mg Monotherapy, 2023, version number 10, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/pembrolizumab-400mg-monotherapy-558.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
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	1

Therapeutic response

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 (+)	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 (+)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab