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About KEYTRUDA®
(pembrolizumab) in Advanced Urothelial Carcinoma

Updated on 11/04/2019

ONCOLOGY

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

NICE recommends pembrolizumab (KEYTRUDA) within the Cancer Drugs Fund (CDF) as an option for locally advanced or metastatic urothelial carcinoma in adults:

  • Who have had platinum-containing chemotherapy,2 OR;
  • For whom cisplatin-based chemotherapy in unsuitable and whose tumours express PD-L1 with a combined positive score (CPS) ≥103

SMC have accepted KEYTRUDA for use as an option within NHS Scotland as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.4

Find out the full details of the NICE recommendation for post-platinum patients, the NICE recommendation for cis-ineligible patients and SMC Guidance for post-platinum.

Please refer to the KEYTRUDA Summary of Product Characteristics and Risk Minimisation Materials before prescribing KEYTRUDA. Risk Minimisation Materials are available online, from your MSD representative or from MSD Medical Information (Email: medicalinformationuk@merck.com, Phone: 01992 467272).

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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guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn.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-00329 | Date of Preparation: April 2019