MedPath
EMA Approval

Oyavas

L01FG01

bevacizumab

Antineoplastic agents

bevacizumab

Colorectal NeoplasmsBreast NeoplasmsOvarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellUterine Cervical Neoplasms

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeL01FG01
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

Oyavas 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. Oyavas can be used in non-small cell lung cancer unless the cancer originates in cells 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 has spread to other parts of the body.

Oyavas 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.

Oyavas is a ‘biosimilar medicine’. This means that Oyavas is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Oyavas is Avastin. For more information on biosimilar medicines, see here.

Oyavas contains the active substance bevacizumab.

Authorisations (1)

EMEA/H/C/005556

STADA Arzneimittel AG,Stadastrasse 2-18,Bad Vilbel,Hessen,61118,Germany

Authorised

March 26, 2021

Active Substances (1)

bevacizumab

Documents (10)

Oyavas : EPAR - Public assessment report

April 15, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Oyavas : EPAR - Public assessment report

April 15, 2021

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Oyavas : EPAR - All authorised presentations

April 15, 2021

AUTHORISED_PRESENTATIONS

Oyavas-H-C-PSUSA-00000403-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

January 5, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Oyavas : EPAR - Risk-management-plan summary

April 15, 2021

RISK_MANAGEMENT_PLAN_SUMMARY

Oyavas : EPAR - Procedural steps taken and scientific information after authorisation

January 28, 2022

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Oyavas

February 1, 2021

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Oyavas : EPAR - Product information

April 15, 2021

DRUG_PRODUCT_INFORMATION

CHMP summary of positive opinion for Oyavas

February 1, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Oyavas : EPAR - Medicine overview

April 15, 2021

OVERVIEW_DOCUMENT

Overview Q&A (7)

Question

Other information about Oyavas

Answer

Oyavas received a marketing authorisation valid throughout the EU on 26 March 2021.

Question

How is Oyavas used?

Answer

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

Oyavas is given by infusion (drip) into a vein. The first infusion of Oyavas should last 90 minutes, but subsequent infusions may be given more quickly if the earlier 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 interrupt or stop treatment if the patient develops certain side effects.

For more information about using Oyavas, see the package leaflet or contact your doctor or pharmacist.

Question

How does Oyavas work?

Answer

The active substance in Oyavas, 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, Oyavas 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.

Question

What benefits of Oyavas have been shown in studies?

Answer

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

In addition, a study involving 627 patients with advanced non-small cell lung cancer showed that Oyavas was as effective as Avastin when given with the cancer medicines paclitaxel and carboplatin. The cancer responded to treatment in 40% of those given Oyavas and 45% of those given Avastin, which was considered comparable.

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

Question

What are the risks associated with Oyavas?

Answer

The safety of Oyavas 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 Oyavas, see the package leaflet.

Oyavas 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.

Question

Why is Oyavas authorised in the EU?

Answer

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Oyavas 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 Oyavas is equivalent to that of Avastin in this indication.

All these data were considered sufficient to conclude that Oyavas 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 Oyavas outweigh the identified risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Oyavas?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oyavas have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Oyavas are continuously monitored. Side effects reported with Oyavas are carefully evaluated and any necessary action taken to protect patients.

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Oyavas - EMA Approval | MedPath