SOUTH SAN FRANCISCO (dpa-AFX) - European Commission has approved Gazyvaro, a glycoengineered monoclonal antibody, for treating chronic lymphocytic leukemia, Roche (RHHBY) said in a statement Tuesday.
Roche expects to start introducing Gazyvaro in a number of European countries this year.
'Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions,' says Sandra Horning, Roches's CMO and head of global product development.
Gazyvaro is the first type II, glycoengineered anti-CD20 monoclonal antibody to be approved in Europe for patients with untreated chronic lymphocytic leukemia, the most common type of the disease.
The European Commission referred to the final-stage trial in which Gazyvaro plus chlorambucil chemotherapy met the primary endpoint by significantly reducing the risk of disease worsening or death by 61 percent, compared with MabThera/Rituxan plus chlorambucil.
The combination of Gazyvaro and chlorambucil also extended the time lived for people who did not receive treatment, compared with those being on chlorambucil alone.
Roche is also studying the effects of Gazyvaro on other blood cancers where anti-CD20 antibodies have been shown to be effective.
Copyright RTT News/dpa-AFX