EU Approves Roche’s Leukemia Drug

01.06.2016 -

The European Commission has approved a subcutaneous formulation of Roche’s MabThera for chronic lymphocytic leukemia (CLL) which saves time and eases the treatment burden compared with the intravenous form of the drug. The approval is indicated for patients with previously untreated and relapsed/refractory forms of the blood cancer. CLL is the most common type of leukemia in the Western world, and mostly affects men.

This is the second European approval for the formulation and follows that for common forms of non-Hodgkin lymphoma in March 2014. Sandra Horning, Roche’s chief medical officer and head of global product development, said MabThera SC provides significantly faster treatment administration and the opportunity to enjoy more time outside clinical settings compared to intravenous delivery.

Approval was based primarily on data from a Phase 1b study which showed that previously untreated CLL patients had comparable concentration levels of the medicine in their blood to intravenous MabThera.

MabThera is a monoclonal antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and cancerous B-cells. It then recruits the body’s natural defences to attack and kill the marked B-cells. The drug has been approved for treating several blood cancers. Roche said it continues to be studied in other types of blood cancers and disease areas where CD20-positive cells are believed to play a role.