Opdivo

RSS

nivolumab

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

Overview

An overview of Opdivo and why it is authorised in the EU

Opdivo is a cancer medicine used to treat the following:

  • melanoma, a type of skin cancer. Opdivo is used on its own or with another cancer medicine, ipilimumab, to treat adults whose cancer has spread to other parts of the body or cannot be surgically removed. It is also used on its own in patients who have had surgery for the removal of melanoma that has spread to the lymph nodes or elsewhere in the body.
  • a lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body. Opdivo is used on its own in patients who have previously been treated with other cancer medicines (chemotherapy);
  • advanced renal cell carcinoma, a kidney cancer. Opdivo is used on its own in patients who have been previously treated with other cancer medicines;
  • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient’s own stem cells to form new bone marrow that produces healthy blood cells). Opdivo is used on its own after treatment with brentuximab vedotin (another cancer medicine);
  • squamous cell cancer of the head and neck (SCCHN) that has come back or spread to other parts of the body. Opdivo is used on its own in patients whose cancer is progressing despite treatment with platinum-based cancer medicines;
  • urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body. It is used on its own when treatment with platinum-based cancer medicines has not worked.

Opdivo contains the active substance nivolumab.

This EPAR was last updated on 25/10/2018

Authorisation details

Product details
Name
Opdivo
Agency product number
EMEA/H/C/003985
Active substance
nivolumab
International non-proprietary name (INN) or common name
nivolumab
Therapeutic area (MeSH)
  • Melanoma
  • Hodgkin Disease
  • Carcinoma, Renal Cell
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XC
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
18/06/2015
Contact address
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Product information

19/09/2018 Opdivo - EMEA/H/C/003985 - PSUSA/00010379/201801

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Melanoma
OPDIVO as monotherapy or in combination with ipilimumab 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.


Adjuvant treatment of melanoma
OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Non-Small Cell Lung Cancer (NSCLC)
OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)
OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.

Classical Hodgkin Lymphoma (cHL)
OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.

Squamous Cell Cancer of the Head and Neck (SCCHN)
OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.

Urothelial Carcinoma
OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

Assessment history

Changes since initial authorisation of medicine

News

How useful was this page?

Add your rating
Average
1 rating
2 ratings