2 Information about pembrolizumab

2 Information about pembrolizumab

In July 2018, the European Medicines Agency restricted the use of pembrolizumab for untreated urothelial carcinoma. It should now only be used in adults with high levels of PD-L1. For more information, see the summary of product characteristics for pembrolizumab.

Marketing authorisation indication

Pembrolizumab (Keytruda, Merck Sharp & Dohme) has a marketing authorisation for 'the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score of 10 or more'.

Dosage in the marketing authorisation

200 mg every 3 weeks by intravenous infusion. The summary of product characteristics recommends treatment with pembrolizumab until disease progression or unacceptable toxicity.


£2,630 per 100 mg vial (excluding VAT; company submission).

The company has a commercial arrangement. This makes pembrolizumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)