生物谷報道：由 Genentech， Biogen Idec 和 Roche 三家制藥公司合作生產(chǎn)美羅華（Rituxan）,，一種治療非何杰金氏淋巴瘤的新藥,，經(jīng)前期試驗表明，美羅華對大明何杰金氏淋巴瘤有良好的效果,，因此這三家公司已聯(lián)合向FDA 遞交申請,，希望能夠擴大其適用人群。該藥原來僅適用于早期病人,。這些公司希望美羅華的標簽上能夠標注上：（與其他化療制劑聯(lián)合使用）治療這一疾病的主要用藥,。
另外，該藥還用于治療關(guān)節(jié)炎等其它病癥,。這一申請?zhí)峤籉DA后,，三家公司的股票應聲上漲。
Biotech companies Genentech Inc. and Biogen Idec Inc. and Swiss drug maker Roche said Wednesday that they filed a supplemental application with the Food and Drug Administration to expand the label for Rituxan to treat a larger population of people with non-Hodgkins lymphoma, a cancer of organs that make up the immune system.
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.
Genentech shares fell 53 cents to $88.43 in morning trading on the New York Stock Exchange, while Biogen shares fell 31 cents to $40.77 on the Nasdaq.
