Onbevzi
Authorised
This medicine is authorised for use in the European Union
bevacizumab
MedicineHumanAuthorised
Overview
Onbevzi is a cancer medicine that is used to treat adults with the following cancers:
- cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
- breast cancer that has spread to other parts of the body;
- a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery. Onbevzi can be used in non-small cell lung cancer unless it originates in cells of a particular type (called squamous cells);
- cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
- cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb and the peritoneum, the membrane that lines the abdomen) that is advanced or has come back after treatment;
- 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.
Onbevzi is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect how well particular medicines work.
Onbevzi is a ‘biosimilar medicine’. This means that Onbevzi is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Onbevzi is Avastin.
Onbevzi contains the active substance bevacizumab.
Onbevzi can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Onbevzi is given by infusion (drip) into a vein. The first infusion of Onbevzi should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion has not caused unacceptable side effects. The dose depends on the patient’s weight, the type of cancer being treated and the other cancer medicines being used. Treatment is continued for as long as the patient benefits from it. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.
For more information about using Onbevzi, see the package leaflet or contact your doctor or pharmacist.
The active substance in Onbevzi, 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 makes new blood vessels grow. By attaching to VEGF, Onbevzi 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 Onbevzi with Avastin have shown that the active substance in Onbevzi is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Onbevzi produces similar levels of the active substance in the body to giving Avastin.
In addition, a study involving 763 patients with advanced non-small cell lung cancer showed that Aybintio was as effective as Avastin when given with the cancer medicines paclitaxel and carboplatin. The cancer responded to treatment in 50% of those given Aybintio and 45% of those given Avastin, which was considered comparable.
Because Onbevzi is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Onbevzi.
The safety of Onbevzi 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 asthenia (weakness), diarrhoea and abdominal (belly) pain. The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries). For the full list of all side effects reported with Onbevzi, see the package leaflet.
Onbevzi 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 (genetically engineered) antibodies. It must not be given to pregnant women.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Onbevzi has a highly similar structure, purity and biological activity to Avastin and is distributed in the body in the same way. In addition, studies in non-small cell lung cancer have shown that the safety and effectiveness of Onbevzi can be considered equivalent to that of Avastin in this indication.
All these data were considered sufficient to conclude that Onbevzi 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 Onbevzi outweigh the identified 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 Onbevzi have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Onbevzi are continuously monitored. Side effects reported with Onbevzi are carefully evaluated and any necessary action taken to protect patients.
Onbevzi received a marketing authorisation valid throughout the EU on 11 January 2021.
Product information
Latest procedure affecting product information: IB/0005
09/03/2023
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
- Onbevzi
- Active substance
- bevacizumab
- International non-proprietary name (INN) or common name
- bevacizumab
- Therapeutic area (MeSH)
- Colorectal Neoplasms
- Breast Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Uterine Cervical Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01FG01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Onbevzi 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, please refer to section 5.1.
Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Onbevzi in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.
Onbevzi, 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.
Onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.
Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.
Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.
Onbevzi, 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.
News on Onbevzi
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