Roche Files MabThera with EU Health Authorities
Roche has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) to extend the current label for its biotechnology drug MabThera (rituximab) in non-Hodgkin’s lymphoma to include maintenance treatment for previously untreated patients with advanced follicular lymphoma.
The filing is based on data from the international phase III PRIMA study which was designed to explore the efficacy of MabThera maintenance therapy following induction treatment with MabThera and chemotherapy in previously untreated patients with advanced follicular lymphoma. The PRIMA study had met its primary endpoint of progression-free survival during a pre-planned interim analysis in September 2009. Data from the trial will be presented at the upcoming 2010 American Society of Clinical Oncology (ASCO) Annual Meeting June 4 - 8 in Chicago.
In the EU, MabThera is currently approved as a maintenance therapy for patients with relapsed or refractory follicular lymphoma who have responded to induction chemotherapy with or without MabThera.