Zirabev
Authorised
This medicine is authorised for use in the European Union
bevacizumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Zirabev is a cancer medicine that is used to treat adults with the following cancers:
- cancer of the colon (large bowel) or the rectum (the last section of the bowel), when it has spread to other parts of the body;
- breast cancer that has spread to other parts of the body;
- a lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Zirabev can be used unless the cancer originates in particular cells called squamous cells;
- cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
- epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen) when the cancer is advanced, or in previously treated patients whose cancer has come back (recurrent);
- cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
Zirabev is used in combination with other cancer medicines, depending on previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.
Zirabev contains the active substance bevacizumab and it is a ‘biosimilar medicine’. This means that Zirabev is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zirabev is Avastin.
Zirabev can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Zirabev is given by infusion (drip) into a vein. The first infusion of Zirabev should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion does not cause troublesome side effects. The dose, which is given every 2 or 3 weeks, depends on the patient’s weight, the type of cancer being treated and what other cancer medicines are being used. Treatment is continued until the cancer is no longer controlled. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.
For more information about using Zirabev, see the package leaflet or contact your doctor or pharmacist.
The active substance in Zirabev, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and encourages the growth of new blood vessels. By attaching to VEGF, Zirabev stops its effect. As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Laboratory studies comparing Zirabev with Avastin have shown that the active substance in Zirabev is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Zirabev produces similar levels of the active substance in the body to giving Avastin.
In addition, a study involving 719 patients with advanced non-small cell lung cancer showed that Zirabev was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel. The cancer improved in 45% of those given Zirabev (162 of 358 patients) and in 45% of those given Avastin (161 of 361).
Because Zirabev is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Zirabev.
The safety of Zirabev has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Avastin.
The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or weakness, diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), bleeding and arterial thromboembolism (blood clots in the arteries). For the full list of side effects with Zirabev, see the package leaflet.
Zirabev must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies. It must not be given to pregnant women.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zirabev has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way. In addition, a study in non-small cell lung cancer has shown that Zirabev’s safety and effectiveness are equivalent to those of Avastin in this condition.
All these data were considered sufficient to conclude that Zirabev will behave in the same way as Avastin in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Avastin, the benefits of Zirabev outweigh the identified risks and it can be authorised in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zirabev have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zirabev are continuously monitored. Side effects reported with Zirabev are carefully evaluated and any necessary action taken to protect patients.
Zirabev received a marketing authorisation valid throughout the EU on 14 February 2019
Product information
Latest procedure affecting product information:
II/0032
05/12/2024
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
- Zirabev
- Active substance
- bevacizumab
- International non-proprietary name (INN) or common name
- bevacizumab
- Therapeutic area (MeSH)
- Colorectal Neoplasms
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01XC07
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status.
Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
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