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About KEYTRUDA®
(pembrolizumab) in Advanced Urothelial Carcinoma

Prescribing Information

Licensed indications1

KEYTRUDA as monotherapy
is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, or, who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥10.

The recommended dose of KEYTRUDA in advanced urothelial cancer is either 200 mg every 3 weeks or 400 mg every 6 weeks administered intravenously over 30 minutes.

KEYTRUDA patient pathway in Advanced Urothelial Carcinoma

Please refer to the KEYTRUDA Summary of Product Characteristics and Risk Minimisation Materials before prescribing KEYTRUDA.

Related content

 

References

  1. KEYTRUDA Summary of Product Characteristics.
  2. NICE – National Institute for Health and Care Excellence (2018) “Final appraisal determination: Pembrolizumab for previously treated advanced or metastatic urothelial cancer”. Available from: https://www.nice.org.uk/guidance/TA519. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
  3. NICE – National Institute for Health and Care Excellence (2018) “Final appraisal determination: Pembrolizumab for untreated PDL1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable”. Available from: https://www.nice.org.uk/guidance/ta522. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
  4. SMC – Following a full submission assessed under the end of life and orphan medicine process: pembrolizumab (KEYTRUDA®) is accepted for restricted use within NHS Scotland. Indication under review: as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-129118/.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-PDO-01167 | Date of Preparation: September 2020