Onbevzi

RSS

bevacizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 05/03/2021

Authorisation details

Product details
Name
Onbevzi
Agency product number
EMEA/H/C/005640
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
L01XC07
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Samsung Bioepis NL B.V.
Date of issue of marketing authorisation valid throughout the European Union
11/01/2021
Contact address

Olof Palmestraat 10
2616 LR Delft
The Netherlands

Product information

11/01/2021 Onbevzi - EMEA/H/C/005640 -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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.

Assessment history

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