Genentech, Biogen submit sBLA for Rituxan in non-Hodgkin's lymphoma

By Lisa Kerner

Erie, Pa., March 30 - Genentech, Inc. and Biogen Idec, Inc. have submitted a supplemental Biologics License Application to the Food and Drug Administration for Rituxan based on efficacy and safety data from two randomized, controlled studies of 644 previously untreated non-Hodgkin's lymphoma (NHL) patients, according to a company news released.

The sBLA is specific for the use of Rituxan (rituximab) as first-line treatment of previously untreated patients with low-grade or follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisone) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy or following CVP chemotherapy.

The first study, a phase 3 trial in 322 patients with follicular, CD20-positive, B-cell NHL, 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.

A phase 3 trial of Rituxan given in a series of infusions over a two-year period to 322 patients met its primary endpoint of an improvement in progression-free survival.

Discovered by Biogen, Rituxan is a therapeutic antibody that targets and selectively depletes CD20-positive B-cells without targeting stem cells or existing plasma cells.

Genentech and Biogen co-market Rituxan in the United States.

Rituxan is already approved as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL, the release stated.

An estimated 360,000 Americans have NHL. Approximately half of NHL patients have a slow-growing, usually incurable (low-grade) form of the disease, the most common type being follicular lymphoma, according to the release.

The safety profile of Rituxan has been established in more than 730,000 patient exposures over a period of eight years.

Genentech discovers, develops, manufactures and commercializes biotherapeutics for unmet medical needs. The company is located in South San Francisco.

Biogen Idec, based in Cambridge, Mass., develops, manufactures and commercializes novel therapies for use in oncology, neurology and immunology.

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