Genentech Inc and Biogen Idec Inc.was granted by the US FDA a priority review to the supplemental Biologics License Application (sBLA) submitted by the companies for Rituxan (Rituximab) in previously-untreated (front-line) patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin's lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.
The FDA grants priority review status to products that are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease.
Based on the designation of priority review, the FDA has up to six months from the submission date, or by the middle of February 2006, to take action on the sBLA submission. The sBLA was submitted on August 12, 2005, claims a company release.
The sBLA filing is based on efficacy and safety data from three randomised, controlled, multicenter studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin's lymphoma. All three trials evaluated the efficacy endpoint of overall survival.
There are currently more than 360,000 people in the United States living with NHL. Approximately 50 percent have aggressive NHL, while the other half have indolent or follicular lymphoma. According to the American Cancer Society, more than 56,000 men and women in the United States are diagnosed with NHL each year.
Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells. Rituxan is also being studied in other hematologic malignancies as well as autoimmune diseases, including rheumatoid arthritis, lupus, multiple sclerosis and ANCA-associated vasculitis.
Rituxan, discovered by Biogen Idec, received FDA approval in November 1997 for the treatment of relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). It was approved in the European Union under the trade name MabThera in June 1998.