Genentech announced that the FDA has approved Rituxan (rituximab) as maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy. This approval was based on data from the Phase 3, international, multicenter, randomized Primary Rituxan and Maintenance (PRIMA) study that enrolled 1,217 patients with previously untreated advanced follicular lymphoma. Study data showed that continuing Rituxan administration every two months for two years in patients who responded to initial treatment with Rituxan plus chemotherapy, nearly doubled progression-free survival compared to those who stopped treatment (based on a hazard ratio of 0.54, 95%CI, 0.42–0.70; p≤0.0001).

Rituxan is already indicated for relapsed or refractory, low-grade or follicular, CD20(+), B-cell non-Hodgkin’s lymphoma (NHL); first-line treatment of follicular, CD20(+), B-cell NHL in combination with CVP chemotherapy; non-progressing (including stable disease), low-grade, CD20(+), B-cell NHL following 1st line CVP chemotherapy; first-line treatment of diffuse large B-cell, CD20(+) NHL in combination with CHOP or other anthracycline-based chemotherapy regimens; and in combination with fludarabine and cyclophosphamide for previously untreated and previously treated CD-20 positive chronic lymphocytic leukemia. Rituxan is also indicated in combination with methotrexate to reduce signs/symptoms and inhibit progression of structural damage in moderately-to-severely active rheumatoid arthritis patients who have had an inadequate response to one or more TNF antagonist therapies.

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