Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg and 400mg) for reimbursement as a first-line treatment option for the treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

This is written in the approval document as:

First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults

Citation

Pembrolizumab 400mg Monotherapy, 2024, version number 12a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6389/558_v12b_Pembrolizumab_400mg_monotherapy.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HSE (1)	MSI-H	Colorectal Adenocarcinoma	Pembrolizumab