Vegzelma

Vegzelma can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.

Vegzelma is available as a concentrate that is made up into a solution for infusion (drip) into a vein. The first infusion of Vegzelma should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well. The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated. The treatment is continued until the patient no longer benefits from it. The doctor may decide to interrupt or stop treatment if the patient develops certain side effects. For more information about using Vegzelma, see the package leaflet or contact your doctor or pharmacist.

The active substance in Vegzelma, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow. By attaching to VEGF, Vegzelma stops its effects. As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, helping to slow down the growth of tumours.

Laboratory studies comparing Vegzelma with Avastin have shown that the active substance in Vegzelma is highly similar to that in Avastin in terms of structure, purity and biological activity. Studies have also shown that giving Vegzelma produces similar levels of the active substance in the body to giving Avastin.

In addition, a main study of 689 patients with non-small cell lung cancer that had come back or spread to other parts of the body showed that Vegzelma was as effective as Avastin in treating the cancer. Around 42% of patients given Vegzelma or Avastin responded to treatment.

Because Vegzelma is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Vegzelma.

The safety of Vegzelma 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 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 Vegzelma, see the package leaflet.

Vegzelma 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, Vegzelma 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 the safety and effectiveness of Vegzelma are equivalent to those of Avastin.

All these data were considered sufficient to conclude that Vegzelma 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 Vegzelma 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 Vegzelma have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Vegzelma are continuously monitored. Suspected side effects reported with Vegzelma are carefully evaluated and any necessary action taken to protect patients.

Vegzelma received a marketing authorisation valid throughout the EU on 17 August 2022.

This overview was last updated in 08-2022.