Genentech, Biogen Idec Submit Rituxan sBLA

Genentech and Biogen Idec have submitted an sBLA to the FDA for the use of Rituxan 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.

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. Also, 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, met its primary endpoint of an improvement in progression-free survival.

Rituxan is 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.