Drug name | Imfinzi®
|
INN | Durvalumab |
API type | Durvalumab is a human monoclonal IgG1κ antibody
|
Pharmacotherapeutic group
| Antineoplastic agents, monoclonal antibodies
|
ATC code
| L01XC28 |
Target of antibody
| PD-L1
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. |
Short description | |
Pharmacodynamic properties
(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
| AstraZeneca |
Marketing authorisation numbers
| EU/1/18/1322/002
|
Marketing authorisation holder
| AstraZeneca AB
SE-151 85 Södertälje
Sweden |
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
Liverpool,
L24 9JW
United Kingdom
alternatively:
MedImmune Pharma B.V.
Lagelandseweg 78
6545CG Nijmegen,
Netherlands |
Max shelf life
| 36 months
|
Storage conditions
| 2°C – 8°C
|
List of excipients
| Histidine
Histidine hydrochloride monohydrate
Trehalose dihydrate
Polysorbate 80 |
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