Yervoy

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ipilimumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 12/05/2022

Authorisation details

Product details
Name
Yervoy
Agency product number
EMEA/H/C/002213
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
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
48
Date of issue of marketing authorisation valid throughout the European Union
13/07/2011
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

22/04/2022 Yervoy - EMEA/H/C/002213 - IB/0097

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Melanoma
YERVOY as monotherapy 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

Changes since initial authorisation of medicine

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