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FDA pulls Avastin's breast cancer approval 已有1人参与
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Avastin's breast cancer indication is no more. The FDA pulled the Roche drug's approval for breast cancer treatment--despite emotional appeals from patients and promises for further study from the drugmaker--saying Avastin has not proven safe and effective for that use. The decision may not have much effect on the drug's sales--analysts tell the New York Times that the expected decline of $1 billion has probably already occurred, and Reuters reports that the company isn't changing its peak sales forecast of 7 billion Swiss francs. But the FDA's choice is sure to touch off more debate about cancer drugs and society's expectations of them. Avastin was initially approved under FDA's fast-track program, which allows meds for life-threatening diseases to come onto the market based on limited data. Cancer, after all, is a scary disease, and U.S. patients tend to expect access to new treatment options as quickly as possible. Roche's Genentech unit was tasked with conducting follow-up trials to prove Avastin's initial promise as a breast-cancer treatment. But when that data came in earlier this year, Avastin's benefits weren't as pronounced as the earlier research suggested. Meanwhile, Avastin had become entrenched as a breast cancer treatment. Some women were convinced that the drug was the only reason they were still alive. Oncologists were split on the issue, as were patient advocacy groups. U.S. lawmakers took up Avastin as a totem for problems in the healthcare industry. Some accused the FDA of moving against Avastin because of the drug's cost. The agency said cost wasn't the issue, but rather science. Roche appealed, but an FDA expert advisory panel sided with the agency, saying the clinical data just didn't support Avastin for breast cancer. Roche made one final plea to the FDA: Keep Avastin's breast cancer approval at least for women who have the fewest options for treating their advanced disease. The company promised more study in the meantime. That pitch didn't work. FDA Commissioner Margaret Hamburg said in a statement it was a "difficult decision," and the agency recognizes how difficult it is for patients to cope with metastatic breast cancer. "But patients must have confidence that the drugs they take are both safe and effective for their intended use," Hamburg said. "After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without ... evidence that use of Avastin will either help them live longer or improve their quality of life." Avastin will remain approved for other uses, including colon, lung, kidney and brain cancer indications. Avastin can of course be used off-label for breast cancer--Medicare and some private payers have said they would pay, regardless of FDA's choice--but other payers might not be so cooperative.Genetech said it still intends to start a new Phase III study of Avastin in combination with paclitaxel and will evaluate a potential biomarker that may help identify those who might benefit most from treatment. "We are disappointed with this outcome," spokeswoman Charlotte Arnold said in an emailed statement. "We remain committed to the many women with this incurable disease and will continue to provide help ... to those who may be facing obstacles to receiving their treatment." |
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美国食物药品管理局在11月18日宣布撤销贝伐珠单抗治疗乳腺癌的批准，因为该药尚未被证实其安全性及针对乳腺癌的有效性。 “这是一个艰难的决定”，FDA委员MargaretHamburg博士在一个新闻发布会上说，“FDA意识到患者及其家属应对进展期乳腺癌的难处，也意识到目前亟待一个更为有效的治疗方案。但患者必须对他们所服用的药物的安全性及有效性有足够的信心。” “通过回顾分析现有的研究，我们清楚认识到，服用阿瓦斯汀治疗进展期乳腺癌的妇女要接受可能危及生命的治疗副作用，而在肿瘤生长延迟方面却欠缺证据表明阿瓦斯汀可以提供治疗获益。同时，目前也没有任何证据表明服用阿瓦斯汀可以延长生存期或改善生活质量。” 贝伐珠单抗相关的副作用风险包括：严重高血压、出血及溶血、诱发心绞痛或心力衰竭、鼻、胃肠道等部位穿孔。FDA表明，目前，贝伐珠单抗仍然批准用于治疗某些结肠、肺、肾脏及脑部的肿瘤。 |
2楼2011-11-21 10:04:10