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Genentech, Biogen Idec Submit Rituxan sBLA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 ...

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