Opdivo

RSS

nivolumab

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

Overview

Opdivo is a cancer medicine used in adults 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);
  • advanced renal cell carcinoma, a kidney cancer;
  • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell);
  • squamous cell cancer of the head and neck (SCCHN);
  • urothelial cancer, a cancer of the bladder and urinary tract.

Opdivo is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or when other treatments do not work.

Opdivo is also used to help prevent the cancer from coming back after patients had surgery to

remove melanoma (adjuvant therapy).

Opdivo can be used on its own and, for some cancers, it can also be used together with ipilimumab and other cancer medicines.

Opdivo contains the active substance nivolumab.

This EPAR was last updated on 25/11/2020

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
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
33
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

05/11/2020 Opdivo - EMEA/H/C/003985 - WS/1783

Contents

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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 in combination with ipilimumab 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.

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.

Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.

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

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