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Information about Keytruda▼

What is it and what is it used for?

Keytruda is a medicine used to treat the following cancers:
  • melanoma (a skin cancer) that has spread or cannot be removed with surgery;
  • a type of lung cancer known as non-small cell lung cancer (NSCLC). Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body;
  • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell). Keytruda is used only after failure of treatments with brentuximab vedotin (another cancer medicine) and a stem cell transplant (ASCT, a type of transplant used to replace the bone marrow with the patient’s own stem cells), or after brentuximab vedotin has failed and a transplant is not possible;
  • urothelial cancer (a cancer of the bladder and urinary tract) that is advanced or has spread to other parts of the body. Keytruda is used in patients who have previously been treated with platinum-based cancer medicines or who cannot be treated with cisplatin-containing cancer medicines.
How Keytruda works
The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and block a cell receptor called PD-1. Some cancers can make a protein that combines with PD-1 to switch off the activity of certain cells of the immune system (the body’s natural defences) preventing them from attacking the cancer. By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.

How Keytruda is used
Keytruda is given as an infusion (drip) into a vein once every three weeks. The recommended dose for previously untreated NSCLC, classical Hodgkin lymphoma and urothelial cancer is 200 mg. For melanoma and previously treated NSCLC, the dose depends on the patient’s weight and is 2 mg per kilogram body weight.

The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe. Treatment is continued until the disease gets worse or side effects become unmanageable.

For patients with lung cancer, doctors should test the tumours to check if the cancer cells produce the PD-L1 protein before starting treatment.

Treatment with Keytruda must be started and supervised by a doctor experienced in the treatment of cancer. The medicine can only be obtained with a prescription.

Product information changes

July 2019
The European Medicines Agency have recommended a new indication for Keytruda.

“Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (kidney cancer) in adults"

Full details will be published shortly.

What are the benefits?

The European Medicines Agency decided that Keytruda’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The Agency considered that study results consistently showed the benefits of Keytruda in patients with advanced melanoma. The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable.

With respect to Non Small Cell Lung Cancer:
A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine). Patients lived longer with Keytruda (around 10 months) than with the other cancer medicines (around 7 months), although Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).

In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 27 (7%) of them, meaning they no longer had any signs of cancer. Agency noted that Keytruda helps prolong survival and slows the worsening of the disease. The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of chemotherapy.

In classical Hodgkin lymphoma, the Agency considered the responses seen so far to be clinically significant in this group of patients, in whom other treatments had failed and who had few other treatment options. The safety of the medicine in this condition otherwise appeared comparable to that in its other uses.

In urothelial cancer, Keytruda helps prolong survival. In previously treated patients, the effects of Keytruda may be delayed and this should be considered when treating patients who have a poor prognosis or aggressive disease. The safety of the medicine in urothelial cancer appeared similar to that in its other uses and compares well to chemotherapy.

What are main side effects?

The most common side effects with Keytruda (which may affect more than 1 in 10 people) are:
  • diarrhoea
  • nausea (feeling sick)
  • itching
  • rash
  • tiredness
Most of these side effects are mild to moderate in severity.

Other common side effects of Keytruda related to the activity of the immune system causing inflammation of body organs. Most will resolve following appropriate treatment or on stopping Keytruda.

For the full list of all side effects and restrictions with Keytruda, see the package leaflet.

Product information changes

June 2019
Manufacturers have updated side effect information adding haemophagocytic lymphohistiocytosis as a rare adverse effect.

Haemophagocytic lymphohistiocytosis (HLH) is a condition in which the body makes too many activated immune cells (macrophages and lymphocytes ).

The signs and symptoms of haemophagocytic lymphohistiocytosis typically develop during the first months or years of life.

However, in rare cases, affected people may not show symptoms until later in childhood or even into adulthood. The features of this condition may include:
  • fever
  • enlarged liver and/or spleen
  • skin rash
  • lymph node enlargement
  • breathing problems
  • easy bruising and/or abnormal bleeding
  • kidney abnormalities
  • heart problems
  • increased risk for certain cancers (leukemia, lymphoma)
Many people with this condition also develop neurologic abnormalities. The neurological symptoms vary but may include irritability, fatigue, abnormal muscle tone, seizures, neck stiffness, mental status changes, ataxia, blindness, paralysis, and/or coma.

What studies have been done?

Skin cancer
Keytruda has been shown to be effective in delaying worsening of melanoma and improving survival. Early results from a study of 540 previously treated melanoma patients showed that 6 months after start of treatment, the disease had not worsened in 34% of patients treated with Keytruda compared with 16% of patients treated with chemotherapy.

A second study looked at 834 patients with melanoma who received either Keytruda or another medicine, ipilimumab. Early results from this study showed that the patients treated with Keytruda lived for up to 5.5 months without their disease getting worse compared with 2.8 months with ipilimumab. The study also found that patients treated with Keytruda lived longer than patients who received ipilimumab. Up to 71% of patients lived for at least 12 months after start of their treatment compared with 58% of patients on ipilimumab.

Lung cancer
Keytruda has been also shown to be effective in delaying worsening of the disease and improving survival in patients with NSCLC that tested positive for the PD-L1 protein.

In a study looking at around 1,000 previously treated patients, patients lived longer with Keytruda (around 11 months) than with another cancer medicine called docetaxel (around 8 months) and the period during which the disease did not get worse was around 4 months with both treatments. Keytruda was more effective in those patients who tested strongly for PD-L1, with these patients living for 15 months on average and for 5 months without their disease worsening.

In a second lung cancer study of 305 patients whose tumours tested strongly for PD-L1 who had not been treated before, patients on Keytruda lived for around 10 months without their disease getting worse compared with 6 months in patients taking platinum-based chemotherapy.

Hodgkin lymphoma
Keytruda has been shown to be effective at partially or completely clearing the cancer cells in classical Hodgkin lymphoma that had not responded to or returned after treatment with brentuximab vedotin, with or without an autologous stem cell transplant.

In a main study of 210 patients, Keytruda produced a complete or partial remission (clearing) of the cancer in 145 patients (69%); a complete remission occurred in 47 (22%) of them, meaning they no longer had any signs of cancer. The average time that the response lasted and patients lived without their disease getting worse again was around 11 months.

Urothelial cancer
Keytruda has been also shown to be effective in improving survival of patients with urothelial cancer.

A study looked at 542 patients previously treated with platinum-based medicines who received either Keytruda or another cancer medicine chosen by the doctor (paclitaxel, docetaxel or vinflunine). Patients lived longer with Keytruda (around 10 months) than with the other cancer medicines (around 7 months), although Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).

In a second study of 370 patients who could not be treated with cisplatin-containing medicines, Keytruda produced a complete or partial remission (clearing) of the cancer in 108 patients (29%); a complete remission occurred in 27 (7%) of them, meaning they no longer had any signs of cancer.

Can patients be prescribed this medicine?

In England and Wales Keytruda has been approved by NICE for the following conditions:
  • locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy (bladder cancer) [TA519]
  • advanced melanoma not previously treated with ipilimumab [TA366]
  • advanced melanoma after disease progression with ipilimumab [TA357]
  • untreated PD-L1-positive metastatic non-small-cell lung cancer [TA447]
  • untreated non-small-cell lung cancer with pemetrexed and platinum based chemotherapy [ID1173]
  • PD-L1-positive non-small-cell lung cancer after chemotherapy [TA428]
Use in classical Hodgkin lymphoma is currently being assessed. A decision is expected in August 2018.

In Scotland Keytruda has been conditionally approved for use in advanced (unresectable or metastatic) melanoma in adults

In Scotland Keytruda has been conditionally approved for use for the following conditions:
  • relapsed or refractory classical Hodgkin lymphoma
  • locally advanced or metastatic non-small cell lung carcinoma (NSCLC)
  • locally advanced or metastatic urothelial carcinoma

Sources

Keytruda was first approved for use in the EU in 2015. It is manufactured by Merck Sharp & Dohme.

European Medicines Agency website page for Keytruda (accessed 27/04/18, updated 15/05/2019)
NICE website
SMC website

Links available in External Resources

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Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).