GENENTECH AND BIOGEN IDEC FILE BIOLOGICS LICENSE APPLICATION

Genentech, Biogen Idec, and Roche have completed the filing of a supplemental biologics license application (sBLA) with the FDA for an additional indication for Rituxan (Rituximab), in previously untreated (front-line) patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin's lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.

As part of the Rituxan sBLA filing, the companies have requested priority review designation from the FDA. Rituxan is currently approved for use in relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma.

The sBLA filing is based on efficacy and safety data from three randomized, 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, CD-20-positive, B-cell, non-Hodgkin's lymphoma. All three trials evaluated the efficacy endpoint of overall survival.