Mvasi (bevacizumab)
- Region
- 🇪🇺 EU
- Active substance
- bevacizumab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
- CHMP opinion
- Wed 08 Nov 2017
- EU approval
- Mon 15 Jan 2018
- Designations
- Biosimilar
- Application
- EMEA/H/C/004728
- ATC
- L01XC07
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Aybintio Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Lytenava Authorised · Outlook Therapeutics NL B. V.
- 🇪🇺 Orblid Application withdrawn · Laboratoires Delbert
- 🇪🇺 Abevmy Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Zirabev Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Avzivi Authorised · FGK Representative Service GmbH
- 🇪🇺 Alymsys Authorised · Mabxience Research SL
- 🇪🇺 Oyavas Authorised · STADA Arzneimittel AG
- 🇪🇺 Vegzelma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Avastin Authorised · Roche Registration GmbH
- 🇪🇺 Onbevzi Withdrawn · Samsung Bioepis NL B.V.
- 🇪🇺 Ipique Refused · Rotterdam Biologics B.V.
Follow Mvasi
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.