What is Opdivo and what is it used for?
Opdivo is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery.
Opdivo is also used to treat non-small cell squamous cancer of the lung (NSCLC, a type of lung cancer) that has spread locally or to other parts of the body in adults previously treated with other anticancer medicines.
Opdivo contains the active substance nivolumab.
How is Opdivo used - Nivolumab?
Treatment with Opdivo should be started and supervised by a specialist doctor experienced in the use of anticancer 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 infusion is given at the recommended dose of 3 mg for each kg of body weight over 60 minutes every two weeks for as long as the patient benefits from it. In the event of certain undesirable effects, the doctor may decide to postpone the administration of the doses or, depending on the severity of the effects, to interrupt the treatment. For more detailed information, see the package leaflet (also included in the EPAR).
How does Opdivo - Nivolumab work?
The active substance in Opdivo, nivolumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and attach to a specific structure, called an antigen, found in certain cells of the body.
Nivolumab is designed to attach to and block a receptor called 'programmed cell death 1' (PD-1), which cancels the activity of certain cells in the immune system (the body's natural defenses) called 'T cells'. By blocking PD-1, nivolumab stops this receptor from inhibiting these immune cells, increasing the immune system's ability to destroy melanoma cells.
What benefit has Opdivo - Nivolumab shown during the studies?
Opdivo has been shown to be effective in the treatment of patients with advanced malignant melanoma and squamous NSCLC.
- In melanoma, Opdivo has been studied in two main studies in patients whose disease could not be treated by surgery or had spread through the body. The first study looked at 418 previously untreated patients with advanced melanoma who were receiving Opdivo or with a standard cancer medicine (dacarbazine). This study revealed that patients treated with Opdivo survived longer than those receiving dacarbazine, with 73% of patients treated with Opdivo still alive after 12 months compared with 42% treated with dacarbazine. The second study involved 405 patients with advanced melanoma, whose disease had worsened despite previous treatment with a standard anticancer medicine. Patients were treated with Opdivo or an anticancer treatment chosen by the researcher (dacarbazine or a combination of carboplatin and paclitaxel) In this study, at the end of which patients stat following for at least 6 months, about 32% (38 out of 120) of patients treated with Opdivo responded to treatment, resulting in a reduction in tumors, compared to about 11% (5 out of 47) of patients treated with the drug chosen by the researcher.
- In NSCLC, Opdivo was studied in one main study involving 272 patients with previous squamous NSCLC that had progressed or spread through the body. Treatment with Opdivo was compared with another anticancer medicine, docetaxel, and the main one. measure of effectiveness was overall survival (how long the patients stayed alive). Overall survival among the 135 patients receiving Opdivo was approximately 9 months, while among the 137 patients taking docetaxel it was 6 months. Supporting information was also provided by another study which revealed that Opdivo could produce a response in patients whose disease had progressed despite previous treatments.
What are the Risks associated with Opdivo - Nivolumab?
The most common side effects with Opdivo (which may affect more than 1 in 10 people) are fatigue, diarrhea, nausea, erythema and itching and decreased appetite, mostly mild to moderate.
Opdivo is also usually associated with side effects due to the activity exerted on organs by the immune system. Most side effects stop with adequate therapy or when treatment with Opdivo is stopped.
For the full list of side effects reported with Opdivo, see the package leaflet.
Why has Opdivo - Nivolumab been 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 had convincingly shown to improve the survival of previously untreated advanced melanoma patients. In subjects who had previously received anticancer therapy, treatment with Opdivo induced a clinically meaningful response.
In squamous NSCLC, Opdivo revealed longer survival than docetaxel in previously treated patients with advanced disease, a patient group for which there are not many treatment options. Patients whose tumors clearly manifested the PD-1 receptor appear to benefit the most, but as other patients have responded, a further study will be required to determine the groups of patients likely to benefit from the medicine. The side effects were thought to be manageable with appropriate measures and were outweighed by the benefits.
What measures are being taken to ensure the safe and effective use of Opdivo - Nivolumab?
A risk management plan has been developed to ensure that Opdivo is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Opdivo, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that makes Opdivo will provide doctors who will prescribe the medicine with educational material containing information on using Opdivo and managing side effects, especially those related to the activity of the immune system. The company will also provide a patient alert card with information on the medicine's risks and when to contact a doctor if symptoms appear. The company will also provide further information on the long-term benefits of Opdivo and will carry out analyzes to try to identify those who are most likely to benefit from treatment with the medicine.
Other information about Opdivo - Nivolumab
On 19 June 2015, the European Commission issued a "marketing authorization" for Opdivo, valid throughout the European Union.
For more information about Opdivo therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2015.
The information on Opdivo - Nivolumab published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
