Basel, 22 March 2010
MabThera filed with EU Health Authorities for maintenance treatment of previously untreated advanced follicular lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it 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 PRIMA1 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.
The PRIMA study is a randomized international phase III study, sponsored by the Groupe d’Etudes de Lymphomes de L’Adulte (GELA) in France and conducted in collaboration with Roche. It included 1217 patients with previously untreated advanced follicular lymphoma and was conducted at 222 study sites across 25 countries. The study was designed to evaluate the efficacy and safety of two-year MabThera maintenance therapy in responders to induction therapy with MabThera plus chemotherapy. The primary objective of the study was to show an increase in terms of progression-free survival.
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
In oncology, MabThera is indicated in the EU:
- For the treatment of patients with previously untreated or relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy; only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy
- For the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
- As maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera
- For the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy
- As monotherapy for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy
In addition, in rheumatology MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
MabThera is known as Rituxan in the United States, Japan and Canada. Across labelled indications, over 2.1 million patient exposures with MabThera/Rituxan have been recorded worldwide since launch, among which almost 1.9 million in hematological malignancies.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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1) Primary Rituximab and Maintenance