Once on 'Fast Track,' Avastin Now Derailed
العنوان: | Once on 'Fast Track,' Avastin Now Derailed |
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المؤلفون: | Jennifer Couzin-Frankel, Yasmin Ogale |
المصدر: | Science. 333:143-144 |
بيانات النشر: | American Association for the Advancement of Science (AAAS), 2011. |
سنة النشر: | 2011 |
مصطلحات موضوعية: | medicine.medical_specialty, Multidisciplinary, Bevacizumab, business.industry, Pharmacology, medicine.disease, Metastatic breast cancer, Food and drug administration, Breast cancer, Chemotherapy Drugs, Family medicine, medicine, Drug approval, Accelerated approval, Fast track, business, health care economics and organizations, medicine.drug |
الوصف: | A unanimous vote last week by advisers to the U.S. Food and Drug Administration (FDA) is likely to sharply curtail access in America to the breast cancer drug Avastin, exposing deep rifts among patient advocates, researchers, and regulators over what kind of scientific backing a drug needs to remain in use. Avastin was approved for breast cancer under FDA9s accelerated approval process, but when follow-up studies showed only a sliver of benefit and serious health risks, FDA announced that it was revoking its approval. Genentech, Avastin9s maker, then sought a reversal, arguing that few treatments are available to women with metastatic breast cancer and that the drug9s performance could vary depending on the chemotherapy drug with which it9s paired. But FDA officials said Avastin9s initial promise simply hasn9t held up. |
تدمد: | 1095-9203 0036-8075 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::efd59e156c80b2cc43af71e8973750ea https://doi.org/10.1126/science.333.6039.143 |
رقم الأكسشن: | edsair.doi...........efd59e156c80b2cc43af71e8973750ea |
قاعدة البيانات: | OpenAIRE |
تدمد: | 10959203 00368075 |
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