Basel, 01 April 2010
Supplemental Biologics License Application submitted for Rituxan for the maintenance treatment of previously untreated advanced follicular lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Genentech, a member of the Roche group, has submitted in collaboration with Biogen Idec a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to extend the current label for its biotechnology drug Rituxan (rituximab) in non-Hodgkin’s lymphoma to include maintenance treatment for previously untreated patients with advanced follicular lymphoma.
The application follows a similar submission to the European Medicine Agency (EMA) earlier this month and is based on data from the international phase III PRIMA1 study which was designed to explore the efficacy of Rituxan maintenance therapy following induction treatment with Rituxan 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.
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 Rituxan maintenance therapy in responders to induction therapy with Rituxan plus chemotherapy. The primary objective of the study was to show an increase in terms of progression-free survival.
Rituxan 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, Rituxan is indicated in the US:
- For the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- For the treatment of NHL for the following:
> Previously untreated follicular, CD20-positive, B-cell NHL in combination with cyclophosphamide, vincristine, prednisolone (CVP) chemotherapy
> Non-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent, after first-line CVP chemotherapy
> Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with standard chemotherapy (CHOP) or other anthracycline-based chemotherapy regimens
- For the treatment of previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC) chemotherapy
In addition, in rheumatology Rituxan in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely-active RA who have had inadequate response to one or more tumor necrosis factor antagonist therapies. Rituxan is not recommended for use in patients with severe active infections.
Rituxan is known as MabThera in Europe. Across labelled indications, over 2.1 million patient exposures with 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.
1) Primary Rituximab and Maintenance
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