|API type||Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
|Antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies
|Target of antibody|
|VEGF-A; Synonyms: vegf, vegfa, wu:fj82c06, VEGF, vegf-a, vpf, vefg, VPF, eVEGF120, eVEGF164, MVCD1, Vegf, Vegf120, Vegf164, Vegf188, Vpf, VEGF164
|General function||inhibits vascular endothelial growth factor A and is commonly used to treat various cancers, including colorectal, lung, breast, kidney, and glioblastomas
|Short description||Bevacizumab is comprised of a tetramer of two heavy and two light chains with one N-glycosylation site per heavy chain Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis
and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and
KDR (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF
regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the
formation of new tumour vasculature, thereby inhibiting tumour growth.
(Mechanism of action; Source EMA document)
|Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in
nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast,
pancreas and prostate. Metastatic disease progression was inhibited and microvascular permeability
MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC). Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC. The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients. The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
In the final population PK model, in addition to primary tumor type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab. However, the magnitude of effect of these covariates on trastuzumab exposure suggests that these covariates.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||n/a
|Original license holder|
|Marketing authorisation numbers|
|EU/1/04/300/001 - 002
|Marketing authorisation holder|
|Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
|Name of the manufacturer of the biological active substance|
1 DNA Way
South San Francisco, CA 94080-4990
1 Antibody Way
Oceanside, CA 92056
F. Hoffmann-La Roche Ltd
Roche Singapore Technical Operations, Pte. Ltd.
10 Tuas Bay Link
|Name and address of the manufacturer(s) responsible for batch release||Roche Pharma AG
|Max shelf life|
|2°C – 8°C
|List of excipients|
Water for injections