Gazyvaro
Authorised
This medicine is authorised for use in the European Union
obinutuzumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Gazyvaro is a medicine used to treat adults with certain types of cancer affecting B cells (a type of white blood cell), called chronic lymphocytic leukaemia and follicular lymphoma, as well as the inflammatory kidney disease lupus nephritis.
Chronic lymphocytic leukaemia
Gazyvaro is used together with chlorambucil (a cancer medicine) in adults who have not been previously treated and have other medical conditions, and for whom the cancer medicine fludarabine is not recommended.
Follicular lymphoma
In patients with advanced follicular lymphoma who have not been previously treated, Gazyvaro is first given together with chemotherapy (other cancer medicines) and then continued on its own in those who benefit from the medicine.
In patients with follicular lymphoma whose disease has not responded to treatment with rituximab, or whose cancer has progressed within 6 months after such treatment, Gazyvaro is given together with bendamustine and then continued on its own in those who benefit from the medicine.
Lupus nephritis
Gazyvaro is used together with mycophenolate mofetil in adults with active lupus nephritis, a condition in which the immune system (the body’s natural defences) attacks the kidneys, causing inflammation and kidney damage. The medicine is for people with active class III or IV lupus nephritis (with or without features of class V), which are severe forms of the condition.
Gazyvaro contains the active substance obinutuzumab
Gazyvaro can only be obtained with a prescription and treatment should be given under the close supervision of an experienced doctor. Because serious side effects such as allergic reactions may occur, treatment should take place in a medical facility where such reactions can be treated promptly.
Gazyvaro is given by infusion (drip) into a vein over several hours.
For the treatment of chronic lymphocytic leukaemia, Gazyvaro is given in six treatment cycles of 28 days each.
For the treatment of follicular lymphoma, Gazyvaro is given in six or eight treatment cycles, each lasting 21 or 28 days. Patients who benefit from treatment then continue taking Gazyvaro once every 2 months for 2 years or until the disease gets worse.
For the treatment of lupus nephritis, the first two infusions are given 2 weeks apart, followed by two further infusions about 6 months later, given two weeks apart. After that, the medicine is given every 6 months.
Before receiving Gazyvaro, the patient should be given medicines to reduce the risk of certain side effects.
For more information about using Gazyvaro, see the package leaflet or contact your doctor or pharmacist.
The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the protein CD20, which is found on B cells.
In chronic lymphocytic leukaemia and follicular lymphoma, cancerous B cells multiply and replace normal cells in the bone marrow (where blood cells are made) and in lymph nodes. By attaching to CD20 on B cells, obinutuzumab makes them a target for the immune system, which kills the B cells.
In lupus nephritis, B cells cause inflammation and damage to the kidneys. By making B cells a target for the immune system to destroy, obinutuzumab lowers their number, thereby reducing inflammation and limiting further damage to the kidneys.
Chronic lymphocytic leukaemia
In a main study involving 781 adults with chronic lymphocytic leukaemia who had not been previously treated, had other medical conditions and were not eligible for fludarabine-based therapy, Gazyvaro delayed the worsening of the disease.
Participants treated with Gazyvaro and chlorambucil lived longer without their disease getting worse than those given chlorambucil alone (on average, 27 months compared with 11 months). Similarly, participants treated with Gazyvaro and chlorambucil lived longer without their disease getting worse than those treated with rituximab and chlorambucil (on average, about 27 months compared with 15 months).
Follicular lymphoma
In a main study involving 1,202 adults with follicular lymphoma who had not been previously treated, Gazyvaro delayed the time when the disease got worse or the person died. The study compared Gazyvaro plus chemotherapy with rituximab plus chemotherapy. Over an average follow-up of about 3 years, 17% (101 out of 601) of those given Gazyvaro had their disease get worse or died, compared with 24% (144 out of 601) of those given rituximab.
Gazyvaro was also studied in 321 adults with follicular lymphoma whose treatment with rituximab had either not worked or had stopped working. Those treated with Gazyvaro and bendamustine lived longer without their disease getting worse than those given bendamustine alone (on average, about 29 months compared with 14 months).
Lupus nephritis
A main study involved 271 adults with active class III or IV lupus nephritis, with or without class V disease, who were already being treated with standard medicines for lupus nephritis (mycophenolate mofetil and corticosteroids). The main measure of effectiveness was the proportion of patients with a complete kidney response after 76 weeks of treatment. Participants were considered to have a complete kidney response when their urine contained low levels of proteins, their kidney filtration remained at least stable, and none of the following occurred: they needed additional treatment, had treatment failure, left the study early or died. After treatment, around 46% of those given Gazyvaro met all three criteria for response, compared with around 33% of those given placebo.
For the full list of side effects and restrictions with Gazyvaro, see the package leaflet.
For the treatment of chronic lymphocytic leukaemia and follicular lymphoma, the most common side effects with Gazyvaro (which may affect more than 1 in 10 people) include upper respiratory tract (throat and nose) infections, pneumonia (lung infection), urinary tract infections, nasopharyngitis (inflammation of the nose and throat), sinusitis (inflammation of the sinuses), shingles, cough, diarrhoea, constipation, joint and back pain, pain in arms and legs, headache, insomnia, hair loss, itching, fever, weakness, tiredness, neutropenia (low levels of neutrophils, a type of white blood cell) and leukopenia (low levels of leucocytes, a type of white blood cell), thrombocytopenia (low levels of platelets in blood), anaemia (low levels of red blood cells) and reactions related to the infusion (which may include vomiting, dizziness, breathing difficulties, flushing, changes in blood pressure and rapid heart rate).
For the treatment of lupus nephritis, the most common side effects with Gazyvaro (which may affect more than 1 in 10 people) include upper respiratory tract infections, COVID-19, urinary tract infections, bronchitis (inflammation of the airways in the lungs), neutropenia, decrease in blood levels of immunoglobulin M (a type of antibody) and reactions related to the infusion.
Studies have shown that Gazyvaro prolonged the time people with chronic lymphocytic leukaemia and follicular lymphoma lived before their disease got worse. For the treatment of lupus nephritis, adding Gazyvaro to standard treatment resulted in an improved kidney response in people with class III and IV disease, with or without class V disease, compared to placebo and standard treatment.
The medicine’s side effects were considered acceptable in view of its benefits, with infections, low levels of neutrophils and infusion-related reactions being the most common. There were some uncertainties about the long-term safety of reducing B-cell levels, which the ongoing study in people with lupus nephritis is expected to address.
The European Medicines Agency therefore decided that Gazyvaro’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gazyvaro have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Gazyvaro are continuously monitored. Suspected side effects reported with Gazyvaro are carefully evaluated and any necessary action taken to protect patients.
Gazyvaro received a marketing authorisation valid throughout the EU on 23 July 2014.
Product information
Latest procedure affecting product information:VR/0000244907
04/12/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Gazyvaro
- Active substance
- obinutuzumab
- International non-proprietary name (INN) or common name
- obinutuzumab
- Therapeutic area (MeSH)
- Leukemia, Lymphocytic, Chronic, B-Cell
- Anatomical therapeutic chemical (ATC) code
- L01FA03
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Chronic lymphocytic leukaemia (CLL)
Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
Follicular Lymphoma (FL)
Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.
Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Lupus nephritis (LN)
Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).
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