|API type||Durvalumab is a human monoclonal IgG1κ antibody
|Antineoplastic agents, monoclonal antibodies
|Target of antibody|
Synonyms: CD274, B7-H, B7H1, PD-L1, PDCD1L1, PDCD1LG1, PDL1, A530045L16Rik, B7h1, Pdcd1l1,
Pdcd1lg1, Pdl1, RGD1566211
|General function||Durvalumab, is a monoclonal antibody, a type of protein designed to recognize and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells, produced in Chinese hamster Ovary (CHO) cells.
(Mechanism of action; Source EMA document)
|Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and 13 tumour-associated immune cells in the tumour microenvironment. PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1). By binding to its receptors, PD-L1 reduces cytotoxic T-cell activity, proliferation and cytokine production.
Durvalumab is a fully human, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that selectively blocks the interaction of PD-L1 with PD-1 and CD80 (B7.1).
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC). Selective blockade of PD-L1/PD-1 and PD-L1/CD80 interactions enhances antitumour immune responses and increases T-cell activation.
|Original license holder|
|Marketing authorisation numbers|
|Marketing authorisation holder|
SE-151 85 Södertälje
|Name of the manufacturer of the biological active substance|
|AstraZeneca Pharmaceuticals LP
Frederick Manufacturing Center (FMC)
633 Research Court
Frederick, Maryland 21703 United States
|Name and address of the manufacturer(s) responsible for batch release||MedImmune UK Ltd
6 Renaissance Way
MedImmune Pharma B.V.
|Max shelf life|
|2°C – 8°C
|List of excipients|
Histidine hydrochloride monohydrate