Yervoy
Authorised
This medicine is authorised for use in the European Union
ipilimumab
MedicineHumanAuthorised
Overview
Yervoy is a cancer medicine used to treat the following:
• advanced melanoma (a type of skin cancer) in adults and adolescents from 12 years of age;
• advanced renal cell carcinoma (a kidney cancer) in adults;
• non-small cell lung cancer (NSCLC) in adults that has spread to other parts of the body (metastatic) and has not been treated before;
• malignant pleural mesothelioma (a cancer of the lining of the lungs) in adults;
• a kind of cancer of the colon or rectum (lower part of the gut) in adults that is described as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
• advanced squamous oesophageal cancer (cancer of the oesophagus, the passage from the mouth to the stomach) in adults that has not been treated before.
Yervoy is usually used in combination with nivolumab (another cancer medicine) but it can also be used on its own for melanoma. For certain cancers, tests to measure the level of a protein called PD-L1 may be needed before treatment with Yervoy in combination with nivolumab. This is because nivolumab works on cancer cells that produce PD-L1.
For renal cell carcinoma, Yervoy is given to patients who have not been treated before and are at moderate or high risk of their cancer getting worse.
For NSCLC, Yervoy is given in combination with both nivolumab and another cancer medicine.
Yervoy contains the active substance ipilimumab.
Yervoy is given by infusion (drip) into a vein. The dose and how often it is given depends on the condition it is being used for and on the patient’s weight.
The doctor may delay doses if certain side effects occur, and stop treatment altogether if side effects are severe.
Yervoy can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
For more information about using Yervoy, see the package leaflet or contact a doctor or pharmacist.
The active substance in Yervoy, ipilimumab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to attach to a specific target in the body.
Ipilimumab increases the number and the activity of a type of white blood cells called T cells which form part of the immune system and which can kill cancer cells. It acts on T cells by attaching to and blocking the activity of CTLA-4, a protein that controls the activity of T cells.
Advanced melanoma
Several studies have shown that Yervoy is effective in prolonging the lives of patients with advanced melanoma.
In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, overall survival with Yervoy alone or with Yervoy combined with an experimental medicine called ‘gp100’ was about 10 months, compared with 6 months in patients receiving gp100 alone.
In a study involving 502 adults whose advanced melanoma had not been treated previously, patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine. However, about one-third of the patients could not complete Yervoy treatment due to side effects.
In a study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg. However, patients treated with the higher dose had more side effects and were less likely to complete treatment as a result. Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.
In two small studies involving a total of 30 adolescents aged 12 to 18 years with advanced melanoma, treatment with Yervoy produced similar levels of medicine in blood as in adults. The effects of Yervoy in adolescents are expected to be similar to those in adults. Because the medicine has been studied in very few adolescents, there is uncertainty about the medicine’s side effects. Therefore, all adolescents treated with Yervoy will be monitored closely.
Finally, two studies found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1. In the first of these studies involving 945 adults, patients treated with Yervoy and nivolumab lived for 11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone. In the second study involving 142 adults, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone. As melanoma in adolescents is similar to the disease in adults and Yervoy behaves in a similar way in adults and adolescents, Yervoy is expected to be as effective in adolescents as it is in adults when used in combination with nivolumab. The data from adults therefore apply to adolescents as well.
Advanced renal cell carcinoma
One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Yervoy and nivolumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib. The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived longer than those given sunitinib. After 24 months, around 67% of patients given the combination were alive compared with 53% in the sunitinib group. In addition, 42% of patients (177 out of 423) responded to the treatment with the combination compared with 27% (112 out of 416) of those receiving sunitinib. The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 months with sunitinib.
Metastatic NSCLC
One main study in 719 adults who had not previously been treated showed that patients given Yervoy in combination with nivolumab and another cancer medicine lived on average for 15.6 months after starting treatment compared with 10.9 months in patients given chemotherapy.
A main study involving 605 patients with malignant pleural mesothelioma that could not be removed by surgery looked at how long patients lived when they received Yervoy with nivolumab or when they received chemotherapy. In this study, patients who received Yervoy and nivolumab lived on average for 18 months while patients who had chemotherapy lived for an average of 14 months.
Cancer of the colon or rectum
A main study involving 119 patients with MSI-H or dMMR colon or rectal cancer examined the effect of treatment with a combination of Yervoy and nivolumab. Around 65% of patients who had the combination responded to treatment and had a reduction in tumour size.
Advanced squamous oesophageal cancer
A main study found that Yervoy in combination with nivolumab prolonged the lives of people with previously untreated squamous oesophageal cancer that could not be removed by surgery, had come back or had spread. The study involved 649 adults who either received Yervoy plus nivolumab or chemotherapy. Patients whose cancer produced PD-L1 protein and who were treated with Yervoy plus nivolumab lived on average for 13.7 months compared with 9.1 months for those treated with chemotherapy. There was no difference between the two treatments in the time patients lived without their disease worsening.
Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation. Most will improve with appropriate treatment or on stopping Yervoy. The most common side effects (which may affect more than 1 in 10 people) are rash, itching, tiredness, diarrhoea, nausea (feeling sick), vomiting, decreased appetite and abdominal (belly) pain.
Yervoy is also commonly associated with side effects related to the activity of the immune system on body organs. Most will go away with appropriate treatment or on stopping Yervoy.
Additional side effects may occur when Yervoy is used with other cancer medicines. For the full list of side effects and restrictions with Yervoy, see the package leaflet.
The European Medicines Agency noted that Yervoy improves survival in melanoma, a condition where overall survival rates are low. The most frequent side effects of the medicine are mild to moderate in severity. Because studies with Yervoy have included very few adolescents, the company has committed to collecting information on side effects, including any effects on growth and sexual maturation.
Yervoy has also been shown to benefit patients with advanced renal cell carcinoma, NSCLC, malignant pleural mesothelioma, cancer of the colon or rectum and squamous oesophageal cancer.
The Agency decided that Yervoy’s benefits are greater than its risks and it can be authorised for use in the EU. In the treatment of melanoma, despite patients living longer with a dose of 10 mg per kg, the Agency recommended using Yervoy at a dose of 3 mg per kg because the higher dose caused more side effects and worsened patients’ quality of life.
The company that markets Yervoy must ensure that patients treated with Yervoy are given a brochure with safety information on the medicine, including the side effects resulting from excessive activity of the immune system. Patients will also receive from their doctor an alert card summarising key safety information on the medicine.
As it is not clear how much Yervoy contributes to the benefits when given in combination with nivolumab in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of Yervoy and if the risks associated with it can be further minimised.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yervoy have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Yervoy are continuously monitored. Side effects reported with Yervoy are carefully evaluated and any necessary action taken to protect patients.
Yervoy received a marketing authorisation valid throughout the EU on 13 July 2011.
Product information
Latest procedure affecting product information: WS2597
15/02/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Yervoy
- Active substance
- Ipilimumab
- International non-proprietary name (INN) or common name
- ipilimumab
- Therapeutic area (MeSH)
- Melanoma
- Carcinoma, Renal Cell
- Carcinoma, Non-Small-Cell Lung
- Mesothelioma, Malignant
- Colorectal Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01XC11
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Melanoma
YERVOY as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).
YERVOY in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).
Renal cell carcinoma (RCC)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).
Non-small cell lung cancer (NSCLC)
YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
Malignant pleural mesothelioma (MPM)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)
YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1).
Oesophageal squamous cell carcinoma (OSCC)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ? 1%.
Assessment history
News on Yervoy
Topics
This page was last updated on