GENENTECH FILES APPLICATION FOR LYMPHOMA DRUG

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Genentech and Biogen Idec have turned in a supplemental use application for Rituxan, their lymphoma drug, to the FDA.

The companies submitted data from a Phase III clinical trial in which Rituxan was used against a different type of lymphoma than it is already approved to treat. Rituxan is already approved for several uses, including as a single agent in patients with relapsed or refractory low-grade or follicular CD20-positive, B-cell non-Hodgkin's lymphoma. The new application asks the FDA to allow its use in previously untreated patients with the disease in combination with other chemotherapy agents like CVP or CHOP.