Opdivo

nivolumab

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This is a summary of the European public assessment report (EPAR) for Opdivo. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Opdivo.

For practical information about using Opdivo, patients should read the package leaflet or contact their doctor or pharmacist.

What is Opdivo and what is it used for?

Opdivo is a cancer medicine used to treat adults with:

  • advanced melanoma, a type of skin cancer that has spread to other parts of the body or cannot be surgically removed. For this purpose, Opdivo is used on its own or together with a medicine called ipilimumab;
  • a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body in patients who have previously been treated with other cancer medicines (chemotherapy);
  • advanced renal cell carcinoma, a type of kidney cancer that has spread throughout the body and cannot be surgically removed. It is only used in patients who have been previously treated with other cancer medicines. For this use, Opdivo is used on its own.

Opdivo contains the active substance nivolumab.

How is Opdivo used?

Treatment with Opdivo must be started and supervised by a doctor experienced in the use of cancer medicines. The medicine can only be obtained with a prescription.

Opdivo is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The dose and frequency to be given depends on whether it is used alone or in combination with ipilimumab. Treatment is given for as long as the patient benefits from it. The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe. For further information, see the package leaflet.

How does Opdivo work?

The active substance in Opdivo, nivolumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.

Nivolumab has been designed to attach to a receptor called PD-1 which is found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from the cancer cells from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.

What benefits of Opdivo have been shown in studies?

Opdivo has been shown to be effective in treating patients with advanced melanoma, NSCLC and advanced renal cell carcinoma:

  • In melanoma, Opdivo used on its own was studied in two main studies in patients with advanced disease. The first study involving 418 previously untreated advanced melanoma patients found that patients treated with Opdivo survived longer than patients who received the cancer medicine dacarbazine: 73% of patients treated with Opdivo were alive at 12 months compared with 42% of patients given dacarbazine. The second study looked at 405 advanced melanoma patients whose disease had got worse despite previous treatment with a cancer medicine. In this study, where patients were followed up for at least 6 months, around 32% (38 out of 120) of patients given Opdivo responded to treatment and had a reduction in their tumours compared with about 11% (5 out of 47) of patients given investigator’s choice of treatment (dacarbazine or a combination of carboplatin and paclitaxel).

An additional study in 945 previously untreated advanced melanoma patients investigated Opdivo in combination with ipilimumab, Opdivo used alone or ipilimumab used alone. Patients who were given Opdivo plus ipilimumab lived for another 11.5 months without their disease getting worse and patients given only Opdivo lived for another 6.9 months without their disease getting worse. Patients given only ipilimumab lived for only 2.9 months without their disease getting worse. The study included patients whose cancer cells produced high levels of PD-L1 as well as patients whose cancer cells produced low levels of PD-L1. Improvements in the time patients lived without their disease getting worse when treated with Opdivo plus ipilimumab relative to Opdivo used on its own were only seen for patients whose cancer cells produced low levels of PD-L1.

  • In NSCLC that had spread locally or to other parts of the body, Opdivo has been shown to improve the average time patients survived compared with docetaxel (another cancer medicine). Studies have shown benefit in two forms of NSCLC, known as non-squamous and squamous.

For non-squamous NSCLC, one main study involved 582 patients whose disease had progressed despite previous treatments. The average survival with Opdivo was around 12.2 months, compared with 9.4 months with docetaxel. For squamous NSCLC, a study involving 272 patients showed that patients given Opdivo survived for around 9.2 months, compared with 6.0 months in patients given docetaxel. Supportive information was also provided from another study indicating that Opdivo could produce a response in patients with squamous NSCLC whose disease had progressed despite several previous treatments.

  • In advanced renal cell carcinoma, Opdivo was compared with everolimus in one main study involving 821 patients whose disease advanced despite previous treatment. Patients given Opdivo survived for around 25.0 months, compared with 19.6 months in patients given everolimus.
What are the risks associated with Opdivo?

The most common side effects with Opdivo (which may affect more than 1 in 10 people) are tiredness, diarrhoea, nausea (feeling sick), rash and pruritus (itching), and decreased appetite, most of which are mild to moderate in severity. These side effects were also the most common side effects when Opdivo was used together with ipilimumab. In addition, hypothyroidism (an underactive thyroid gland), vomiting, colitis (inflammation of the gut), abdominal pain, arthralgia (joint pain) and headache were seen.

Opdivo is also commonly associated with side effects related to the activity of the immune system on body organs. Most will resolve following appropriate treatment or on stopping Opdivo.

For the full list of all side effects and restrictions with Opdivo, see the package leaflet.

Why is Opdivo approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Opdivo’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC or renal cell carcinoma) by either increasing patients’ survival or the time they could live without their disease getting worse. Side effects were considered manageable with appropriate measures and were outweighed by the benefits.

What measures are being taken to ensure the safe and effective use of Opdivo?

The company that makes Opdivo will provide educational packs for doctors who are expected to prescribe Opdivo containing information on how the medicine should be used and how to manage side effects, particularly side effects related to the activity of the immune system. The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms. The company will also provide further data on the long-term benefits of Opdivo and carry out analyses to try to identify which patients are most likely to benefit from treatment with the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opdivo have also been included in the summary of product characteristics and the package leaflet.

Other information about Opdivo

The European Commission granted a marketing authorisation valid throughout the European Union for Opdivo on 19 June 2015.

For more information about treatment with Opdivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Opdivo : EPAR - Summary for the public BG = bălgarski 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public ES = español 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public CS = čeština 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public DA = dansk 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public DE = Deutsch 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public ET = eesti keel 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public EL = elliniká 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public EN = English 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public FR = français 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public IT = italiano 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public LV = latviešu valoda 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public LT = lietuvių kalba 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public HU = magyar 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public MT = Malti 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public NL = Nederlands 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public PL = polski 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public PT = português 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public RO = română 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public SK = slovenčina 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public SL = slovenščina 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public FI = suomi 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public SV = svenska 16/07/2015 27/06/2016
Opdivo : EPAR - Summary for the public HR = Hrvatski 16/07/2015 27/06/2016
Name Language First published Last updated
Opdivo : EPAR - Risk-management-plan summary (English only) 16/07/2015  

This EPAR was last updated on 19/07/2016 .

Authorisation details

Product details

Product details for Opdivo
NameOpdivo
Agency product numberEMEA/H/C/003985
Active substance

nivolumab

International non-proprietary name (INN) or common name

nivolumab

Therapeutic area Melanoma
Anatomical therapeutic chemical (ATC) code L01XC
Additional monitoring

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

Publication details

Publication details for Opdivo
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision5
Date of issue of marketing authorisation valid throughout the European Union19/06/2015

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park 
Sanderson Road 
Uxbridge UB8 1DH 
United Kingdom

Product information

Product information

20/06/2016  Opdivo -EMEA/H/C/003985 -IB/0016

Name Language First published Last updated
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016
Opdivo : EPAR - Product Information EN = English 16/07/2015 19/07/2016

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.


Name Language First published Last updated
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  
Opdivo : EPAR - All Authorised presentations EN = English 16/07/2015  

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) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.

Non-Small Cell Lung Cancer (NSCLC)

Opdivo is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)

Opdivoas monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Opdivo : EPAR - Public assessment report EN = English 16/07/2015  
CHMP summary of positive opinion for Opdivo EN = English 24/04/2015