Basic Information
Yervoy
Regulatory Information
EMEA/H/C/002213
July 13, 2011
May 19, 2011
58
July 22, 2024
Company Information
Ireland
Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867
Bristol-Myers Squibb Pharma EEIG
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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%.
Overview Summary
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.