Drug name | Bavencio®
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INN | Avelumab |
API type | Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
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Pharmacotherapeutic group
| Antineoplastic agents, monoclonal antibodies
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ATC code
| L01XC31 |
Target of antibody
| PD-L1; Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1,
Pdcd1lg1, Pdl1, RGD1566211 |
General function | Avelumab is used to treat adults with Merkel cell carcinoma (MCC), a rare type of skin cancer when it is metastatic (has spread to other parts of the body).
PD-L1 is found on the surface of MCC cells and helps protect tumour cells from the immune system (the body’s natural defences). Avelumab binds to PD-L1, and blocks this protective effect, allowing the immune system to attack the tumour cells. (Source EMA , package leaflet) |
Short description | |
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
| Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1). Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors. This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses.
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Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Avelumab has also shown to induce natural killer (NK) cell-mediated direct tumour cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC). |
Original license holder
| Merck Europe B.V. |
Marketing authorisation numbers
| EU/1/17/1214/001
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Marketing authorisation holder
| Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands
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Name of the manufacturer of the biological active substance
| Merck Serono SA
Succursale de Corsier-sur-Vevey
Chemin du Fenil - Zone Industrielle B,
1804 Corsier-sur-Vevey
Switzerland |
Name and address of the manufacturer(s) responsible for batch release | Merck Serono S.p.A.
Via Delle Magnolie 15 (loc. frazione Zona Industriale)
70026 - Modugno (BA)
Italy
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Max shelf life
| 24 months
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Storage conditions
| 2°C – 8°C
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List of excipients
| Mannitol
Glacial acetic acid
Polysorbate 20
Sodium hydroxide |
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