Gazyvaro, a new, type II, glycoengineered monoclonal antibody, is marketed as Gazyva outside of the EU and Switzerland.
It is designed to attach to CD20, a protein found only on B cells and it attacks targeted cells both directly and together with the body’s immune system.
Roche chief medical officer and Global Product Development head Sandra Horning said the company is happy to make Gazyvaro available for CLL patients in Europe.
"Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions," Horning said.
The approval was based on data from the CLL11 study which was carried out in close collaboration with the German CLL Study Group.
In the trial, Gazyvaro plus chlorambucil met its primary endpoint by reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival (PFS)).
In addition, Gazyvaro data from the CLL11 study demonstrated higher complete response rates and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity compared to the MabThera/Rituxan arm of the study.
The company expects to launch Gazyvaro in a number of European countries in 2014 for CLL patients in Europe.
Gazyvaro was discovered by Roche Glycart, a part of the company’s Pharma Research and Early Development organization.
Image: Gazyvaro is a new, type II, glycoengineered monoclonal antibody marketed as Gazyva outside of the EU and Switzerland. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net