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FDA pulls Avastin's breast cancer approval 已有1人參與
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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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美國食物藥品管理局在11月18日宣布撤銷貝伐珠單抗治療乳腺癌的批準(zhǔn)，因為該藥尚未被證實其安全性及針對乳腺癌的有效性。 “這是一個艱難的決定”，F(xiàn)DA委員MargaretHamburg博士在一個新聞發(fā)布會上說，“FDA意識到患者及其家屬應(yīng)對進(jìn)展期乳腺癌的難處，也意識到目前亟待一個更為有效的治療方案。但患者必須對他們所服用的藥物的安全性及有效性有足夠的信心。” “通過回顧分析現(xiàn)有的研究，我們清楚認(rèn)識到，服用阿瓦斯汀治療進(jìn)展期乳腺癌的婦女要接受可能危及生命的治療副作用，而在腫瘤生長延遲方面卻欠缺證據(jù)表明阿瓦斯汀可以提供治療獲益。同時，目前也沒有任何證據(jù)表明服用阿瓦斯汀可以延長生存期或改善生活質(zhì)量。” 貝伐珠單抗相關(guān)的副作用風(fēng)險包括：嚴(yán)重高血壓、出血及溶血、誘發(fā)心絞痛或心力衰竭、鼻、胃腸道等部位穿孔。FDA表明，目前，貝伐珠單抗仍然批準(zhǔn)用于治療某些結(jié)腸、肺、腎臟及腦部的腫瘤。 |
2樓2011-11-21 10:04:10
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