Therapeutic Avelumab antibody from the original Bavencio® commercial drug
|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.
|Pharmacotherapeutic group||Antineoplastic agents, monoclonal antibodies
|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)
(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.
|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
|Marketing authorisation holder||Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
|Name of the manufacturer of the biological active substance||Merck Serono SA
Succursale de Corsier-sur-Vevey
Chemin du Fenil - Zone Industrielle B,
|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)
|Max shelf life||24 months
|Storage conditions||2°C – 8°C
|List of excipients||Mannitol
Glacial acetic acid
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