following a full submission:
pembrolizumab (Keytruda®) is accepted for use within NHSScotland.
Indication under review: in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, for the treatment of adults with locally advanced, or early stage triple-negative breast cancer (TNBC) at high risk of recurrence.
In a randomised, double-blind phase III study, the addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab monotherapy significantly improved the pathological complete response rate and event-free survival compared with placebo.
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.
Download detailed advice790KB (PDF)
Medicine details
- Medicine name:
- pembrolizumab (Keytruda)
- SMC ID:
- SMC2538
- Indication:
In combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery) for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence.
- Pharmaceutical company
- Merck Sharp & Dohme Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 12 June 2023