|Pembrolizumab is a humanized monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilizing sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology
|Antineoplastic agents, monoclonal antibodies
|Target of antibody
|PD-1; Synonyms: CD279, PD1, SLEB2, hPD-1, hPD-l, Ly101, Pdc1
|Pembrolizumab is a humanized monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2.
(Mechanism of action; Source EMA document)
|The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Pembrolizumab potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumors or other cells in the tumor microenvironment.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)
|No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. The use of systemic corticosteroids or immunosuppressants before starting pembrolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of pembrolizumab. However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions.
|Original license holder
|Merck Sharp & Dohme B.V.
2031 BN Haarlem
|Marketing authorisation numbers
|Marketing authorisation holder
|Merck Sharp & Dohme Limited
Hertfordshire EN11 9BU
|Name of the manufacturer of the biological active substance
C Frederick Manufacturing Center (FMC)
633/636/660 Research Court Frederick
MD 21703-8619, USA
Boehringer Ingelheim (BIB)
Pharma GmbH & Co. KG
Birkendorfer Straße 65
88397 Biberach an der Riss
|Name and address of the manufacturer(s) responsible for batch release
|Schering-Plough Labo NV
Industriepark 30, Heist-op-den-Berg
|Max shelf life
|2°C – 8°C
|List of excipients
L-histidine hydrochloride monohydrate