Yervoy

RSS

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.

Yervoy is usually used in combination with nivolumab (another cancer medicine) but it can also be used on its own for melanoma.

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 20/11/2020

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
Anatomical therapeutic chemical (ATC) code
L01XC11
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
12/07/2011
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

05/11/2020 Yervoy - EMEA/H/C/002213 - WS/1783

Contents

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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.

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.

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.

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.

Assessment history

Changes since initial authorisation of medicine

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