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.
Mvasi : EPAR - Medicine overview (PDF/136.85 KB)
First published: 31/01/2018
Last updated: 30/04/2020
Mvasi : EPAR - Risk-management-plan summary (PDF/78.38 KB)
First published: 21/05/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Amgen Technology (Ireland) UC
|Date of issue of marketing authorisation valid throughout the European Union||
20/12/2022 Mvasi - EMEA/H/C/004728 - PSUSA/00000403/202202
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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).
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.
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.