Onbevzi
Withdrawn
This medicine's authorisation has been withdrawn
bevacizumab
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 11 December 2023, the European Commission withdrew the marketing authorisation for Onbevzi (bevacizumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Samsung Bioepis NL B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Onbevzi was granted marketing authorisation in the EU on 11 January 2021 for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. The marketing authorisation was initially valid for a 5-year period.
Onbevzi was a duplicate application to Aybintio, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Aybintio. The European Public Assessment Report (EPAR) for Onbevzi is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IB/0005
11/12/2023
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:
- 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).
Product details
- Name of medicine
- Onbevzi
- 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
- L01FG01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
News on Onbevzi
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