following a full submission:
pembrolizumab (Keytruda®) is accepted for restricted use within NHSScotland.
Indication under review: as monotherapy for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.
In an open-label, phase III study, pembrolizumab monotherapy was associated with significantly improved progression-free survival compared with investigator’s choice of chemotherapy in patients with metastatic MSI-H/dMMR colorectal cancer.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
Medicine details
- Medicine name:
- pembrolizumab (Keytruda)
- SMC ID:
- SMC2375
- Indication:
As monotherapy for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
- Pharmaceutical company
- Merck Sharp & Dohme Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 13 September 2021