following a full submission:
pembrolizumab (Keytruda®) is accepted for use within NHSScotland.
Indication under review:
As monotherapy for adults with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in the following settings:
- treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy.
As monotherapy for the treatment of the following MSI-H or dMMR tumours in adults with:
- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
In two phase II, single-arm studies, pembrolizumab demonstrated objective response rates from 34% to 56% in patients with MSI-H or dMMR tumours.
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:
- SMC2589
- Indication:
As monotherapy for the treatment of the following MSI H or dMMR tumours in adults with:
- unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy;
- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;
- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
- Pharmaceutical company
- Merck Sharp & Dohme Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 15 January 2024