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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

Our oncology portfolio

KEYTRUDA® monotherapy


The following license indications are currently unavailable in the NHS as they are either not funded, awaiting funding approval or have not been submitted for funding.

Classical Hodgkins Lymphoma (cHL)

Full indication: KEYTRUDA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.

Registration study: Keynote 87

European Market Authorisation: May 2017

Funding status: Ongoing

England: NICE statement around funding:

  1. Pembrolizumab is not recommended for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin.
  1. Pembrolizumab is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had brentuximab vedotin and cannot have autologous stem cell transplant, only if:
    • pembrolizumab is stopped after 2 years of treatment or earlier if the person has a stem cell transplant or the disease progresses and
    • the conditions in the managed access agreement for pembrolizumab are followed
  1. These recommendations are not intended to affect treatment with pembrolizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Please see https://www.nice.org.uk/guidance/ta540/chapter/1-Recommendations for further information.

Scotland: Pembrolizumab (KEYTRUDA®) is accepted for restricted use within NHS Scotland. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.

In a phase II study, pembrolizumab was associated with a clinically meaningful overall response rate in adults with classical Hodgkin lymphoma who had failed autologous stem cell transplant and brentuximab vedotin, or who were transplant-ineligible and had failed brentuximab vedotin. Please see https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-129618/ for further information.

Wales: Excluded due to NICE appraisal. Please see https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals/pembrolizumab-keytruda6/ for further information.

Head and Neck Squamous Cell Carcinoma (HNSCC)

Full indication: KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) and progressing on or after platinum-containing chemotherapy

Registration study: Keynote 40

European Market Authorisation: September 2018

Funding status: Final

England: NICE is unable to make a recommendation about the use in the NHS of pembrolizumab (Keytruda) for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy because no evidence submission was received from Merck Sharp & Dohme. We will review this decision if the company decides to make a submission'. Please see https://www.nice.org.uk/guidance/ta570 for further information.

Scotland: Pembrolizumab (KEYTRUDA®) is not recommended for use within NHS Scotland. MSD did not make a formal submission to the SMC. Please see https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-nonsub-smc2143/ for further information.

Wales: No formal statement from All Wales Medicine Strategy Group regarding this indication and NICE appraisal TA570.

KEYTRUDA® in combination


The following license indications are currently unavailable in the NHS as they are either not funded, awaiting funding approval or have not been submitted for funding.

Head and Neck Squamous Cell Carcinoma (HNSCC)

Full indication: KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1

Registration study: Keynote 48

European Market Authorisation: November 2019

Funding status: Ongoing

England: Pembrolizumab in combination is not recommended and is excluded from NICE recommendation.

1.1 Pembrolizumab is recommended as an option for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a combined positive score (CPS) of 1 or more. This is only if:

- pembrolizumab is given as a monotherapy

- pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if disease progresses, and

- the company provides pembrolizumab according to the commercial arrangement (see section 2 of the NICE guidance)

1.2 This recommendation is not intended to affect treatment with pembrolizumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Please see https://www.nice.org.uk/guidance/gid-ta10181/documents/html-content-3 for further information.

Scotland: Pembrolizumab (KEYTRUDA®) in monotherapy and in combination is accepted for restricted use within NHS Scotland. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. Please see https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2257/ for further information.

Wales: Excluded due to NICE appraisal. Please see https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals/pembrolizumab-keytruda/ for further information.

Find out more about KEYTRUDA (pembrolizumab) in combination with platinum and 5-fluorouracil (5-FU) chemotherapy:

Find out more

Renal Cell Carcinoma (RCC)

Full indication: KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

Registration study: Keynote 426

European Market Authorisation: September 2019

Funding status: Final

England: 1.1 Pembrolizumab with axitinib is not recommended, within its marketing authorisation, for untreated advanced renal cell carcinoma in adults.

1.2 This recommendation is not intended to affect treatment with pembrolizumab plus axitinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Please see https://www.nice.org.uk/guidance/ta650 for further information.

Scotland: Pembrolizumab (KEYTRUDA®) is accepted for restricted use within NHS Scotland. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. Please see Please see https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2247/ for further information.

Wales: Excluded due to NICE appraisal. Please see https://awmsg.nhs.wales/medicines-appraisals/pembrolizumab-keytruda1/ for further information.

Find out more about KEYTRUDA (pembrolizumab) in combination with axitinib:

Find out more

5-FU = 5-Fluorouracil; ASCT = Autologous Stem Cell Transplant; BV = Brentuximab Vedotin; cHL = Classical Hodgkins Lymphoma; CPS= Combined Positive Score; HNSCC = Head and Neck Squamous Cell Carcinoma; PD-L1 = Programmed Death-Ligand 1; RCC = Renal Cell Carcinoma; TPS = Tumor Proportion Score

Supporting documentation

KEYTRUDA® (pembrolizumab)
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-PDO-01552 | Date of Preparation: April 2021