What is Keytruda - Pembrolizumab and what is it used for?
Keytruda is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery.
Keytruda contains the active substance pembrolizumab
How is Keytruda used - Pembrolizumab?
Treatment with Keytruda should be started and supervised by a specialist doctor experienced in the use of anticancer medicines. 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 the recommended dose of 2 mg per kilogram of body weight over 30 minutes every three weeks. In the event of certain undesirable effects, the doctor may decide to postpone the administration of the doses or, depending on the severity of the effects, to interrupt the treatment. Treatment should continue until the disease gets worse or unmanageable side effects appear.
For more information, see the package leaflet.
How does Keytruda - Pembrolizumab work?
The active substance in Keytruda, pembrolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and attach to a specific structure, called an antigen, found in certain cells of the body.
Pembrolizumab is designed to attach to and block a receptor called 'programmed cell death 1' (PD-1), which cancels the activity of certain cells in the immune system (the body's natural defenses) called 'T cells'. By blocking PD-1, pembrolizumab stops this receptor from inhibiting these immune cells, increasing the immune system's ability to destroy melanoma cells.
What benefit has Keytruda - Pembrolizumab shown during the studies?
Keytruda has been shown to be effective in treating patients with melanoma that is inoperable or has spread throughout the body in two main studies.
The first study included 540 patients who had previously been treated with another monoclonal antibody used in melanoma therapy, ipilimumab. Patients were treated with Keytruda at a dose of 2 mg / kg body weight every three weeks or at a dose of 10 mg / kg body weight every three weeks or with chemotherapy (medicines used in the treatment of cancer). The first results showed that, 6 months after the start of treatment, the disease had not worsened in 34% of patients treated with Keytruda compared to 16% of patients treated with chemotherapy.
The second study looked at 834 patients not previously treated with ipilimumab who were given either Keytruda or ipilimumab. Initial results showed that patients treated with Keytruda survived up to 5.5 months without disease progression compared to 2.8 months for patients treated with ipilimumab. The study also found that overall survival was higher in subjects treated with Keytruda than in patients treated with ipilimumab. Up to 71% of patients survived at least 12 months from initiation of therapy compared with 58% of subjects treated with ipilimumab.
What is the risk associated with Keytruda - Pembrolizumab?
The most common side effects with Keytruda (which may affect more than 1 in 10 people) are diarrhea, nausea, itching, erythema, arthralgia (joint pain) and fatigue, which are mostly mild to moderate. Other common side effects with Keytruda related to the activity of the immune system, which is responsible for organ inflammation. Most side effects go away with adequate therapy or when treatment with Keytruda is stopped.
For the full list of side effects reported with Keytruda and their restrictions, see the package leaflet.
Why has Keytruda - Pembrolizumab been 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 took into account that the results of the Available studies, although not definitive, have revealed the benefits of Keytruda in subjects with advanced melanoma. The safety profile was considered favorable compared to other treatments, including ipilimumab and chemotherapy, and the side effects are manageable with the recommendations existing.
What measures are being taken to ensure the safe and effective use of Keytruda - Pembrolizumab?
A risk management plan has been developed to ensure that Keytruda is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Keytruda, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that makes Keytruda will provide prescribing doctors with educational material containing information on using Keytruda and managing side effects, especially those related to the activity of the immune system. The company will also provide a patient alert card with information on the medicine's risks and when to contact a doctor if symptoms appear.
The company will also make available the final results of the ongoing studies with Keytruda to confirm the long-term benefits of the medicine. Finally, the company will further evaluate the doses of 2 mg / kg and 10 mg / kg body weight in specific patients and will carry out tests to better understand which individuals can benefit most from treatment with Keytruda.
Other information about Keytruda - Pembrolizumab
On 17 July 2015, the European Commission issued a "marketing authorization" for Keytruda, valid throughout the European Union.
For more information about Keytruda therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2015.
The information on Keytruda - Pembrolizumab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
