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Genentech and Biogen Idec File Lymphoma Treatment


Posted on 2006-03-30 09:11:00



Genentech, Inc. and Biogen Idec, Inc.  have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of Rituxan (Rituximab) as first-line treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy or following CVP chemotherapy in those patients who achieved a response of stable disease or better.

The sBLA submission is primarily based on efficacy and safety data from two randomized, controlled studies of Rituxan in 644 previously-untreated patients. The first study was a Phase III trial in 322 patients with follicular, CD20-positive, B-cell NHL that met its primary endpoint of an improvement in progression-free survival when Rituxan was used in combination with CVP chemotherapy as compared to CVP chemotherapy alone.

The submission also includes data from a Phase III trial of Rituxan given in a series of infusions over a two year period of time designed to evaluate efficacy and safety in 322 patients who had achieved a response or demonstrated stable disease to first-line CVP chemotherapy and who were then randomized either to receive Rituxan or observation. This study, E1496, a National Cancer Institute-sponsored intergroup trial led by the Eastern Cooperative Oncology Group, met its primary endpoint of an improvement in progression-free survival.

Rituxan is already approved as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL; Rituxan in combination with CHOP or other anthracycline-based chemotherapy was approved in February as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Also in February, Rituxan was approved in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.


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