Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.
Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).
Bavencio contains the active substance avelumab.
Bavencio : EPAR - Medicine overview (PDF/112.62 KB)
First published: 13/10/2017
Last updated: 04/11/2019
Bavencio : EPAR - Risk-management-plan summary (PDF/259.47 KB)
First published: 04/11/2019
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This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Merck Europe B.V.
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24/10/2019 Bavencio - EMEA/H/C/004338 - II/0009/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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OTHER ANTINEOPLASTIC AGENTS
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).