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Vegzelma

Published
Product name
Vegzelma
Active ingredient
Bevacizumab
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
How this medicine works

Bevacizumab is an antineoplastic agent containing the active ingredient, bevacizumab. Bevacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutralises the biologic activity of human vascular endothelial growth factor (VEGF). 
Bevacizumab contains human framework regions with antigen binding regions of a humanised murine antibody that binds to VEGF. Bevacizumab is produced by recombinant deoxyribonucleic acid (DNA) technology in a Chinese hamster ovary mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. 
Bevacizumab inhibits the binding of VEGF to its receptors, fms-like tyrosine kinase-1 (Flt-1) and kinase insert domain receptor (KDR), on the surface of endothelial cells. Neutralising the biologic activity of VEGF reduces the vascularisation of tumours, thereby inhibiting tumour growth. 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 was reduced.
 

Why the TGA approved or did not approve this medicine

The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Vegzelma was considered favourable for the therapeutic use approved.