Mvasi

RSS

bevacizumab

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

Overview

Mvasi 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. Mvasi 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 or the peritoneum, the membrane that lines the abdomen);
  • 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.

Mvasi 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 its sensitivity to particular medicines.

Mvasi is a ‘biosimilar medicine’. This means that Mvasi is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Mvasi is Avastin.

This EPAR was last updated on 05/01/2023

Authorisation details

Product details
Name
Mvasi
Agency product number
EMEA/H/C/004728
Active substance
bevacizumab
International non-proprietary name (INN) or common name
bevacizumab
Therapeutic area (MeSH)
  • Carcinoma, Renal Cell
  • Peritoneal Neoplasms
  • Ovarian Neoplasms
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Fallopian Tube Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC07
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
Amgen Technology (Ireland) UC
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
15/01/2018
Contact address

Pottery Road
Dun Laoghaire
Co. Dublin
Ireland

Product information

20/12/2022 Mvasi - EMEA/H/C/004728 - PSUSA/00000403/202202

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

Mvasi 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.

Mvasi, 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.

Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.

Mvasi, 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 IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Mvasi, 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.

Mvasi in combination with paclitaxel, 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.

Mvasi, 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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