Zirabev (bevacizumab)
- Region
- 🇪🇺 EU
- Active substance
- bevacizumab
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
- CHMP opinion
- Thu 13 Dec 2018
- EU approval
- Thu 14 Feb 2019
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004697
- ATC
- L01XC07
- Official record
- www.ema.europa.eu
Indication
Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Zirabev 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. Zirabev, 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. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Zirabev, 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
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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.