What is Nivolumab BMS and what is it used for?
Nivolumab BMS is a cancer medicine used to treat adult patients with a form of lung cancer called squamous non-small cell lung cancer (NSCLC). It is used in patients whose disease has spread locally or to other parts of the body and who have previously been treated with other anticancer medicines (chemotherapy).
The drug contains the active ingredient nivolumab.
How is Nivolumab BMS used?
Nivolumab BMS can only be obtained with a prescription. Therapy should be started and supervised by a doctor experienced in treating cancer.
It is available as a concentrate for the preparation of a solution for infusion (drip) into a vein. The recommended dose is 3 mg of nivolumab per kilogram of body weight administered intravenously for 60 minutes, every two weeks until the patient benefits. It may be necessary to delay the administration of doses or to stop treatment if the patient develops some serious side effects. For more information, see the package leaflet.
How does Nivolumab BMS work?
The active substance in Nivolumab BMS 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) present in certain cells in the body.
The antigen to which Nivolumab binds is a receptor called "programmed cell death 1" (PD-1), which turns off the activity of some cells of the immune system (the body's natural defenses) called T cells. binds to PD-1, nivolumab blocks the receptor preventing it from turning off these immune cells. This increases the ability of the immune system to kill cancer cells.
What benefit has Nivolumab BMS shown during the studies?
Nivolumab BMS has been shown to improve patient survival in one main study involving 272 patients with previously treated squamous NSCLC that has progressed or spread to other parts of the body. Treatment with Nivolumab BMS was compared with another anticancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long the patients lived). The median survival of the 135 patients treated with Nivolumab BMS was about 9 months, while in the 137 patients treated with docetaxel it was 6 months. Useful information was also provided by another study that showed that Nivolumab BMS can produce a response in patients whose disease has progressed despite several previous treatments.
What is the risk associated with Nivolumab BMS?
The most common side effects with Nivolumab BMS (which may affect up to 1 in 10 people) are tiredness, decreased appetite and nausea, mostly mild or moderate.
Nivolumab BMS 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 Nivolumab BMS treatment.
For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
Why has Nivolumab BMS been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nivolumab BMS's benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been associated with greater survival than docetaxel in patients with previously treated advanced squamous NSCLC, a group of patients who have poor treatment options. Patients whose cancer has clearly expressed PD-1 appear to have received more benefits, but given that other patients have responded to treatment, further studies are needed to identify the groups of patients most likely to receive benefits from the medicine. The side effects were considered manageable by appropriate measures and were offset by the benefits.
What measures are being taken to ensure the safe and effective use of Nivolumab BMS?
A risk management plan has been developed to ensure that Nivolumab BMS 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 Nivolumab BMS, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that produces Nivolumab BMS will provide doctors who will be prescribing the medicine with informative material containing information on the use of Nivolumab BMS and on the management of undesirable effects, particularly 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 information on when to contact the doctor in the event of symptoms appearing. The company will also carry out further studies on the benefits of Nivolumab BMS in the long term and will seek to identify those most likely to benefit from the treatment with the medicine.
More information on Nivolumab BMS
On 20 July 2015, the European Commission issued a marketing authorization for Nivolumab BMS, valid throughout the European Union.
For more information about treatment with Nivolumab BMS, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2015.
