April 29, 2016
Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance for the treatment of people with follicular lymphoma. Approximately 19,000 people in Europe are diagnosed with follicular lymphoma each year, which is the most common type of indolent (slow-growing) non-Hodgkin lymphoma. This sort of lymphoma is considered incurable, and the situation of most people deteriorate rapidly.
“Each time a person with follicular lymphoma experiences a progression of their disease, it becomes harder to treat. Progressive disease is particularly challenging after MabThera-containing therapy, and this CHMP positive opinion for Gazyvaro brings us one step closer to providing a much needed new treatment option for follicular lymphoma patients in Europe,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
A final decision regarding the approval of Gazyvaro is expected from the European Commission in the coming months based on this positive CHMP recommendation. EU has already approved Gazyvaro in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (CLL) and comorbidities, making them unsuitable for full-dose fludarabine based therapy.