What is Gazyvaro - obinutuzumab used for?
Gazyvaro is an anticancer medicine that contains the active substance obinutuzumab . It is used in combination with chlorambucil (another anticancer medicine) in the treatment of adult patients with chronic lymphatic leukemia (LLC). CLL is a cancer of B lymphocytes, a type of white blood cell. Gazyvaro is used in patients with CLL who are also simultaneously suffering from other medical conditions that make them unsuitable for a therapy based on a medicine known as "fludarabine". Because the number of patients with CLL is low, the disease is considered 'rare' and Gazyvaro was designated an 'orphan medicine' (a medicine used in rare diseases) on 10 October 2012.
How is Gazyvaro - obinutuzumab used?
Gazyvaro can only be obtained with a prescription and treatment must be administered under the careful supervision of an experienced doctor, in a facility with equipment suitable for managing any serious side effects. Gazyvaro is available as a concentrate for solution for infusion (drip into a vein) over a few hours. Treatment with Gazyvaro includes six cycles of 28 days each. Day 1 of the first cycle is administered by infusion over a four-hour period, under the careful supervision of a doctor in the event of infusion-related reactions, with a dose of 100 mg. On day 2, a dose of 900 mg is given; however, if no infusion-related reactions develop after the first dose is administered, this second dose may be administered on the same day as the first. Subsequently, on days 8 and 15 of the first cycle, a dose of 1, 000 mg is administered. In the remaining 5 cycles, the dose of 1, 000 mg is administered only on day 1. Patients also receive other medicines to reduce the risk of developing infusion-related reactions and other side effects, as appropriate. For more information, see the package leaflet.
How does Gazyvaro - obinutuzumab work?
The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody, which is a type of protein designed to recognize and bind to the CD20 protein, which is present on the surface of all B lymphocytes. In CLL, pathological B lymphocytes multiply too quickly, replacing the normal cells of the spinal cord (the place where blood cells are formed), and are unable to function properly. By binding to the CD20 protein present on the B lymphocytes of CLL patients, obinutuzumab causes the death of these abnormal lymphocytes. The monoclonal antibody present in Gazyvaro is produced by a method known as "recombinant DNA technology": that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce the antibody.
What benefit has Gazyvaro - obinutuzumab shown during the studies?
Gazyvaro has been shown to significantly delay the progression of CLL in previously untreated patients suffering from other medical conditions and therefore not suitable for fludarabine therapy. In one main study involving 781 patients, subjects treated with Gazyvaro and chlorambucil lived on average significantly longer without signs of disease progression compared to patients treated with chlorambucil alone (respectively 26.7 months compared to 11, 1 months). Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer without disease progression than those treated with rituximab (another monoclonal antibody) and chlorambucil (on average 26.7 months compared to 15.2 months).
What is the risk associated with Gazyvaro - obinutuzumab?
The most common side effects with Gazyvaro (which may affect more than 1 in 10 people) are infusion-related reactions (such as fever, pain, chills and low blood pressure), neutropenia (decreased white blood cell count), thrombocytopenia (decrease in the number of platelets in the blood), anemia (decrease in the number of red blood cells in the blood), diarrhea and pyrexia (fever). Serious side effects include tumor lysis syndrome (a complication due to the breakdown of cancer cells), heart problems and, very rarely, progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death). For the full list of side effects and limitations, see the package leaflet.
Why has Gazyvaro - obinutuzumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Gazyvaro's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the benefit of Gazyvaro in prolonging the survival of CLL patients before disease progression was clearly demonstrated. As for safety, the toxicity profile was considered acceptable with respect to the benefit provided.
What measures are being taken to ensure the safe and effective use of Gazyvaro - obinutuzumab?
A risk management plan has been developed to ensure that Gazyvaro 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 Gazyvaro, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Gazyvaro - obinutuzumab
On 23 July 2014, the European Commission issued a marketing authorization for Gazyvaro, valid throughout the European Union. For more information on Gazyvaro therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The summary of the opinion of the Committee for Orphan Medicinal Products related to Gazyvaro is available on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / Rare disease designation. Last update of this summary: 07-2014.
