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Lymphoma and Pets
Genentech files for wider Rituxan use
The companies said they have requested a priority review from the FDA. If granted, the agency would decide on the supplemental application within six months rather than the standard 10 months.
Rituxan is currently approved as a treatment for low-grade non-Hodgkins lymphoma patients who have failed other therapies or who have relapsed. The supplemental application seeks to expand Rituxan's labeling to be used as a front-line, or first, treatment used in combination with other chemotherapy regimens for patients with intermediate or aggressive forms of the disease.
The application included clinical data from 1,854 previously untreated patients and used overall survival as a primary endpoint. The companies are also studying Rituxan as a treatment for rheumatoid arthritis, a condition when the immune system inappropriately attacks joint tissue, causing inflammation and destroying cartilage, tendons and bones, often resulting in disability.