2 Information about pembrolizumab (monotherapy or in combination)

2 Information about pembrolizumab (monotherapy or in combination)

Marketing authorisation indication

2.1 Pembrolizumab (Keytruda, Merck Sharp & Dohme) has a UK marketing authorisation as monotherapy or with platinum and 5-fluorouracil (5-FU) chemotherapy 'for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS [combined positive score] ≥ 1'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.


2.3 Pembrolizumab costs £2,630 for a 100-mg vial, excluding VAT (BNF online, accessed December 2019).

2.4 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)