Drug Action
Pembrolizumab is a monoclonal antibody, which binds to the programmed death-1 (PD-1) receptor, thereby potentiating an immune response to tumour cells.
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Drug reference
Pembrolizumab is a monoclonal antibody, which binds to the programmed death-1 (PD-1) receptor, thereby potentiating an immune response to tumour cells.
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Melanoma (specialist use only) | Non-small cell lung cancer (as monotherapy) (specialist use only) | Urothelial carcinoma (specialist use only) | Classical Hodgkin lymphoma (specialist use only) | Head and neck squamous cell carcinoma (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 200 mg every 3 weeks, alternatively 400 mg every 6 weeks, for dose adjustments due to side-effects or infusion-related reactions—consult product literature Non-small cell lung cancer (as combination therapy) (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 200 mg every 3 weeks, for dose adjustments due to side-effects or infusion-related reactions—consult product literature
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Patients may need pretreatment to minimise the development of adverse reactions (consult product literature)
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NICE decisions ▶Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab (updated September 2017) NICE TA357 Pembrolizumab (Keytruda ®) is recommended as an option for treating advanced (unresectable or metastatic) melanoma in adults only: . after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or MEK inhibitor, and . the manufacturer provides pembrolizumab in line with the commercial access agreement with NHS England. www.nice.org.uk/guidance/ta357 ▶Pembrolizumab for advanced melanoma not previously treated with ipilimumab (updated September 2017) NICE TA366 Pembrolizumab (Keytruda ®) is recommended as an option for treating advanced (unresectable or metastatic) melanoma that has not been previously treated with ipilimumab, in adults, only when the manufacturer provides pembrolizumab in line with the commercial access agreement with NHS England. www.nice.org.uk/guidance/ta366 ▶Pembrolizumab for adjuvant treatment of resected melanoma with high risk of recurrence (December 2018) NICE TA553 Pembrolizumab (Keytruda ®) is recommended for use within the Cancer Drugs Fund as an option for the adjuvant treatment of stage III melanoma with lymph node involvement in adults who have had complete resection. It is recommended only if the conditions in the managed access agreement for pembrolizumab are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta553 ▶Pembrolizumab for treating PD-L1-positive non-small-cell lung cancer after chemotherapy (updated September 2017) NICE TA428 Pembrolizumab (Keytruda ®) is recommended as an option for treating locally advanced or metastatic PD-L1-positive non-small-cell lung cancer in adults who have had at least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive tumour), only if: . pembrolizumab is stopped at 2 years of uninterrupted treatment and no documented disease progression, and . the manufacturer provides pembrolizumab in line with the commercial access agreement with NHS England. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they or their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta428 ▶Pembrolizumab for untreated PD-L1-positive metastatic non- small-cell lung cancer (July 2018) NICE TA531 Pembrolizumab (Keytruda ®) is recommended as an option for untreated PD-L1-positive metastatic non-small-cell lung cancer in adults whose tumours express PD-L1 (with at least a 50% tumour proportion score) and have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations, only if: . pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression, and . the manufacturer provides pembrolizumab according to the commercial access agreement. www.nice.org.uk/guidance/ta531 ▶Pembrolizumab with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer (January 2019) NICE TA557 Pembrolizumab (Keytruda ®), with pemetrexed and platinum chemotherapy is recommended for use within the Cancer Drugs Fund, as an option for untreated, metastatic, non-squamous non-small-cell lung cancer in adults whose tumours have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations. It is only recommended if: . pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if disease progresses, and . the manufacturer provides pembrolizumab according to the managed access agreement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta557 ▶Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer (September 2019) NICE TA600 Pembrolizumab (Keytruda ®), with carboplatin and paclitaxel, is recommended for use within the Cancer Drugs Fund as an option for untreated metastatic squamous non-small cell lung cancer in adults, only if: . pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if disease progresses, and . the manufacturer provides pembrolizumab according to the managed access agreement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta600 ▶Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy (April 2018) NICE TA519 Pembrolizumab (Keytruda ®) is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy, only if: . pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression, and . the conditions in the managed access agreement for pembrolizumab are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta519 ▶Pembrolizumab for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable (updated July 2018) NICE TA522 Pembrolizumab (Keytruda ®) is recommended for use within the Cancer Drugs Fund as an option for untreated locally advanced or metastatic urothelial carcinoma in adults when cisplatin-containing chemotherapy is unsuitable, only if: . their tumours express PD-L1 with a combined positive score of 10 or more, and . pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses, and . the conditions of the managed access agreement for pembrolizumab are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta522 ▶Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma (September 2018) NICE TA540 Pembrolizumab (Keytruda ®) is not recommended for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta540 ▶Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma (September 2018) NICE TA540 Pembrolizumab (Keytruda ®) 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. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta540 Scottish Medicines Consortium (SMC) decisions SMC No. 1086/15 The Scottish Medicines Consortium has advised (November 2015) that pembrolizumab (Keytruda ®) is accepted for use within NHS Scotland as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults previously untreated with ipilimumab. The advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 1087/15 The Scottish Medicines Consortium has advised (December 2016) that pembrolizumab (Keytruda ®) is not recommended for use within NHS Scotland as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults previously treated with ipilimumab as the economic case was not demonstrated. SMC No. SMC2144 The Scottish Medicines Consortium has advised (May 2019) that pembrolizumab (Keytruda ®) is accepted for use within NHS Scotland as monotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete Immune system and malignant disease resection. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 1204/17 The Scottish Medicines Consortium has advised (January 2017) that pembrolizumab (Keytruda ®) is accepted for restricted use within NHS Scotland for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) and who have received at least one prior chemotherapy regimen, subject to a two-year clinical stopping rule. The advice is contingent upon the continuing availability of pembrolizumab at the price agreed in the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 1239/17 The Scottish Medicines Consortium has advised (July 2017) that pembrolizumab (Keytruda ®) is accepted for restricted use within NHS Scotland as monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a 50% tumour proportion score with no epidermal growth factor receptor or anaplastic lymphoma kinase positive tumour mutations, subject to a two-year clinical stopping rule. The advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. SMC2187 The Scottish Medicines Consortium has advised (September 2019) that pembrolizumab (Keytruda ®) is accepted for restricted use within NHS Scotland in combination with carboplatin and either paclitaxel or nab- paclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand 1 (PD- L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Treatment with pembrolizumab is subject to a two- year clinical stopping rule. The advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. SMC2207 The Scottish Medicines Consortium has advised (October 2019) that pembrolizumab (Keytruda ®) is accepted for restricted use within NHS Scotland when used in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor or anaplastic lymphoma kinase-positive mutations, and whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour progression score (TPS) or in whom it has not been possible to evaluate PD- L1 TPS. Treatment with pembrolizumab is subject to a two-year clinical stopping rule. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 1291/18 The Scottish Medicines Consortium has advised (February 2018) that pembrolizumab (Keytruda ®) is accepted for restricted use within NHS Scotland as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum- containing chemotherapy. Treatment with pembrolizumab is subject to a two-year clinical stopping rule. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. Immune system and malignant disease SMC No. 1339/18 The Scottish Medicines Consortium has advised (September 2018) that pembrolizumab (Keytruda ®) is not recommended for use within NHS Scotland as monotherapy, 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 (CPS)10, as the economic case was not demonstrated. SMC No. 1296/18 The Scottish Medicines Consortium has advised (March 2018) that pembrolizumab (Keytruda ®) is accepted for restricted use within NHS Scotland as monotherapy for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin. Treatment with pembrolizumab is subject to a two-year clinical stopping rule. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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MHRA/CHM ADVICE: PEMBROLIZUMAB (KEYTRUDA ®): REPORTS OF ORGAN TRANSPLANT REJECTION (JULY 2017) A European review of worldwide data concluded that pembrolizumab may increase the risk of rejection in organ transplant recipients. The MHRA recommends considering the benefit of treatment with pembrolizumab versus the risk of possible organ transplant rejection for each patient.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Abdominal pain. anaemia. appetite decreased. arthralgia. arthritis. asthenia. chills. constipation. cough. cytokine release syndrome. diarrhoea. dizziness. dry mouth. dyspnoea. fever. gastrointestinal disorders. headache. hypersensitivity. hyperthyroidism. hypothyroidism. influenza like illness. infusion related reaction. myositis. nausea. oedema. pain . pneumonitis. severe cutaneous adverse reactions (SCARs). skin reactions. taste altered. vomiting ▶Uncommon Adrenal insufficiency. alopecia. decreased leucocytes. dry eye. electrolyte imbalance. eosinophilia. epilepsy. hair colour changes. hepatitis. hypertension. hypophysitis. insomnia. lethargy. myocarditis. nephritis. nerve disorders. neutropenia. pancreatitis. tenosynovitis. thrombocytopenia. thyroiditis. type 1 diabetes mellitus. uveitis ▶Rare or very rare Erythema nodosum. haemolytic anaemia . myasthenic syndrome. sarcoidosis ▶Frequency not known Solid organ transplant rejection SIDE-EFFECTS, FURTHER INFORMATION Immune-related reactions Most immune-related adverse reactions are reversible and managed by temporarily stopping treatment and administration of a corticosteroid—consult product literature for further information. Infusion-related reactions Manufacturer advises to permanently discontinue treatment in patients with severe infusion reactions.
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Manufacturer recommends effective contraception during treatment and for at least 4 months after treatment in women of Immune system and malignant disease childbearing potential.
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Manufacturer advises avoid unless potential benefit outweighs risk—no information available
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Manufacturer advises avoid—no information available.
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Manufacturer advises monitor for signs and symptoms of infusion- and immune- related reactions. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator at 2–8°C.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion CAUTIONARY AND ADVISORY LABELS 3 ▶Keytruda (Merck Sharp & Dohme Ltd) A Pembrolizumab 25 mg per 1 ml Keytruda 100mg/4ml concentrate for solution for infusion vials | 1 vial P £2,630.00 (Hospital only) Powder for solution for infusion CAUTIONARY AND ADVISORY LABELS 3 ▶Keytruda (Merck Sharp & Dohme Ltd) A Pembrolizumab 50 mg Keytruda 50mg powder for concentrate for solution for infusion vials | 1 vial P £1,315.00 (Hospital only)
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Patients should be provided with an alert card and advised to keep it with them at all times.
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200 mg every 3 weeks, alternatively 400 mg
First-line fragment. Read the complete Indications and Dose section above.
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200 mg every 3 weeks, for dose adjustments due
First-line fragment. Read the complete Indications and Dose section above.
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