* Files for label extension in Europe
* Filing follows successful Phase III trial
(Adds details, background)
ZURICH, March 22 (Reuters) - Swiss drugmaker Roche Holding AG ROG.VX is looking to broaden the use of its cancer drug MabThera in non-Hodgkin’s lymphoma in Europe, underscoring the strength of its position in oncology.
Roche, the world’s largest maker of cancer drugs, has filed MabThera with the European Medicines Agency to extend its label to include maintenance treatment for previously untreated patients with advanced follicular lymphoma.
Advanced follicular lymphoma is a low grade, or slow growing, non-Hodgkin’s lymphoma and is the most common type of lymphoma, which is a cancer of the lymphatic system.
Roche’s filing comes after MabThera, known as Rituxan in the United States where it is co-marketed with Biogen Idec Inc (BIIB.O), met its primary goal of progression-free survival in a late-stage trial.
The trial was designed to look at the efficacy of MabThera maintenance therapy after induction treatment with MabThera in previously untreated patients with the disease.
MabThera was approved more than a decade ago to treat non-Hodgkin’s leukemia and was approved in 2006 as a treatment for adults with moderate to severe rheumatoid arthritis.
MabThera is already approved as a maintenance therapy in the EU for patients with relapsed or refractory follicular lymphoma who have responded to induction chemotherapy with or without MabThera. (Reporting by Katie Reid; Editing by David Holmes)