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Active Substance: pembrolizumab
Common Name: pembrolizumab
ATC Code: L01
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Active Substance: pembrolizumab
Status: Authorised
Authorisation Date: 2015-07-17
Therapeutic Area: Melanoma
Pharmacotherapeutic Group: Antineoplastic agents

Therapeutic Indication

Keytruda as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Keytruda is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received approved therapy for these mutations prior to receiving Keytruda.

What is Keytruda and what is it used for?

Keytruda is a cancer medicine used to treat adults with:

  • melanoma, a skin cancer, which has spread to other parts of the body or cannot be surgically removed;
  • non-small cell lung cancer (NSCLC), which has spread nearby or to other parts of the body in patients who have previously been treated with at least one chemotherapy regimen. Keytruda is specifically for lung tumours that produce a protein known as PD-L1.

The medicine contains the active substance pembrolizumab.

How is Keytruda used?

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.

Keytruda is available as a powder that is made up into a solution for infusion (drip) into a vein. The infusion is given at a recommended dose of 2 mg per kilogram body weight over 30 minutes every three weeks. 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.

For further information, see the summary of product characteristics.

How does Keytruda work?

The active substance in Keytruda, pembrolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Pembrolizumab has been designed to attach to and block a receptor called PD-1, which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.

What benefits of Keytruda have been shown in studies?

Keytruda has been shown to be effective in treating patients with melanoma and non-small cell lung cancer.

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.

A third study looked at around 1,000 patients with lung cancer who had had at least one previous chemotherapy treatment and whose tumours produced PD-L1. In patients whose tumours tested strongly for PD-L1, overall survival was higher after Keytruda treatment (around 15 months) than after treatment with another cancer medicine docetaxel (around 8 months). The period during which the disease did not get worse in this group of patients was also higher with Keytruda: around 5 months versus 4 months with docetaxel.

Keytruda was also effective in the larger group of patients with lung cancer, including those whose tumours were not strongly positive for PD-L1.

What are the risks associated with Keytruda?

The most common side effects with Keytruda (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), itching, rash, joint pain and tiredness, most of which 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.

Why is Keytruda approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Keytruda’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that available study results, although not final, 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 NSCLC, the CHMP 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 docetaxel.

What measures are being taken to ensure the safe and effective use of Keytruda?

The company that makes Keytruda will provide educational packs for doctors who are expected to prescribe Keytruda containing information on how the medicine should be used and how to manage side effects, particularly side effects on the immune system. The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.

In addition, the company will provide the final results of the studies with Keytruda to confirm the long-term benefits of the medicine. Moreover, the company will further evaluate the 2 mg/kg and 10 mg/kg dose in specific patients and will also carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Keytruda have also been included in the summary of product characteristics and the package leaflet.

Other information about Keytruda

The European Commission granted a marketing authorisation valid throughout the European Union for Keytruda on 17 July 2015.

For more information about treatment with Keytruda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.