Opdivo

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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;
  • 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;
  • malignant pleural mesothelioma (a cancer of the lining of the lungs);
  • a kind of cancer of the colon or rectum (lower part of the gut) that is described as microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR);
  • squamous oesophageal cancer (cancer of the oesophagus, the passage from mouth to stomach);
  • oesophageal cancer and gastro-oesophageal junction cancer (cancer at the junction between the stomach and the oesophagus) after chemotherapy, radiotherapy and surgery;
  • gastric (stomach), gastro-oesophageal junction or oesophageal adenocarcinoma.

Opdivo is mainly used when cancers that are advanced, unresectable (cannot be removed by surgery) or have spread to other parts of the body (metastatic) or when other treatments do not work.  

For melanoma, oesophageal cancer, gastro-oesophageal junction cancer and urothelial cancer, Opdivo is also used to help prevent the cancer from coming back after patients have had surgery (adjuvant therapy).

Opdivo works on cancer cells that produce a protein called PD-L1, and tests may be needed before treatment to check that treatment with Opdivo is suitable.

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

Opdivo contains the active substance nivolumab.

This EPAR was last updated on 10/05/2022

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
  • Carcinoma, Transitional Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Urologic Neoplasms
  • Mesothelioma
  • Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01FF01
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
49
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

25/04/2022 Opdivo - EMEA/H/C/003985 - PSUSA/00010379/202107

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

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 (see sections 4.4 and 5.1).

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 (see section 5.1).

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.

Malignant pleural mesothelioma (MPM)

Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

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 (see section 5.1).

Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1).

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 (see section 5.1).

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.

Adjuvant treatment of urothelial carcinoma

OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1).

Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)

Opdivo in combination with ipilimumab 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)

OPDIVO in combination with ipilimumab 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%.

OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy 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%.

Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.

Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (OC or GEJC)

Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1).

Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinoma

OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.

Assessment history

Changes since initial authorisation of medicine

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