Opdivo - Nivolumab

What is Opdivo - Nivolumab 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 surgically removed.

Opdivo is also used to treat squamous non-small cell lung cancer (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 ingredient nivolumab.

How is Opdivo - Nivolumab used?

Treatment with Opdivo must be started and followed by a specialist doctor who is experienced in the use of anticancer medicines. The medicine can only be obtained with a prescription.

Opdivo is available as a concentrate to be reconstituted in a solution for infusion (drip into a vein). The infusion is administered at the recommended dose of 3 mg per kg of body weight over 60 minutes every two weeks for as long as the patient benefits. In the event of the occurrence of certain side 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 with 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 bind to a specific structure, called an antigen, found in certain cells of the body.

Nivolumab was designed to bind and block a receptor called "programmed cell death 1" (PD-1), which cancels the activity of some cells of the immune system (the body's natural defenses) called "T cells". By blocking PD-1, nivolumab prevents 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 was effective in treating 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 in the body. The first study examined 418 previously untreated advanced melanoma patients who received Opdivo or a standard anticancer 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, in which the disease had worsened despite previous treatment with a standard anticancer medicine. Patients were treated with Opdivo or with a cancer treatment chosen by the researcher (dacarbazine or a combination of carboplatin and paclitaxel). In this study, at the end of which patients were followed for at least 6 months, approximately 32% (38 out of 120) of patients treated with Opdivo responded to treatment, with a reduction in tumors, compared with approximately 11% (5 out of 47) of patients treated with the medicine chosen by the researcher.
In NSCLC, Opdivo was examined in one main study involving 272 patients with a previous squamous NSCLC that had progressed or had spread in the body. Treatment with Opdivo was compared with another anticancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long patients remained alive). Overall survival among the 135 patients who received Opdivo was around 9 months, while among the 137 patients taking docetaxel 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 undesirable effects due to the activity exerted on the organs by the immune system. Most side effects cease with adequate therapy or with discontinuation of Opdivo treatment.

For the full list of all 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 demonstrated improvements in the survival of patients with advanced stage untreated melanoma. In subjects who had previously undergone cancer therapy previously, treatment with Opdivo induced a clinically significant response.

In squamous NSCLC, Opdivo revealed a greater survival than docetaxel in previously treated patients and with an advanced disease, a group of patients for which there are not many treatment options. Patients whose tumors manifested the PD-1 receptor clearly seem to derive the maximum benefit, but since other patients have responded, it will be necessary to carry out an additional study to determine the groups of patients likely to benefit from the medicine. Undesirable effects were considered manageable with appropriate measures and were offset by 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 included in the summary of product characteristics and the package leaflet for Opdivo, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that produces Opdivo will provide doctors who will prescribe the medicine with informative material containing information on the use of Opdivo and on the management of undesirable effects, in particular those related to the activity of the immune system. The company will also provide an alert card for patients, accompanied by information on the risks of the medicine and indications on when to contact the doctor when symptoms appear. The company will also transmit further information on Opdivo's long-term benefits and will perform analyzes to try to identify those most likely to benefit from the treatment with the medicine.