FDA因為嚴重副作用撤回使用乳腺癌藥物癌思停

FDA因為嚴重副作用撤回使用乳腺癌藥物癌思停
FDA pulls use of breast cancer drug Avastin because of severe side effects
Last updated at 5:48 PM on 18th November 2011
Translation by Autumnson Blog

The blockbuster drug Avastin should no longer be used in advanced breast cancer patients because of dangerous side effects.
重磅炸彈藥物癌思停應該不再被用於晚期乳腺癌癌症患者身上，由於危險的副作用。
The Food and Drug Administration declared Friday there is no proof that the drug extends the lives of advanced patients.
食品和藥物管理局週五宣布，沒有證據表明該藥物延長晚期患者的生命。
The ruling by the FDA was long expected, but it was certain to disappoint women who say they've run out of other options as their breast cancer spread through their bodies. Impassioned patients had lobbied furiously to preserve Avastin as a last shot.
FDA的裁決早有預期，但它一定會令失望婦女，她們說當她們的乳腺癌蔓延全，她們已缺乏其它選擇。 慷慨激昂的患者曾拼命遊說去維護癌思停作為最後一槍。

Not applicable: Avastin will no longer be used for breast cancer patients, but is used in the treatment of some colon, lung, kidney and brain cancers
不適用：癌思停將不再被用於乳腺癌患者，但被用於一些結腸、肺、腎和腦腫瘤的治療

'This was a difficult decision,' said FDA Commissioner Margaret Hamburg.

She added that 'it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks.'
Those risks include severe high blood pressure, massive bleeding, heart attack or heart failure, and perforations in parts of the body such as the stomach and intestines, Ms Hamburg said.
Avastin is the world's best-selling cancer drug, and also is used to treat certain forms of colon, lung, kidney and brain cancers. So even though FDA formally revoked its approval of the drug to treat breast cancer, doctors still could prescribe it — but insurers may not pay for it.
Including infusion fees, a year's treatment with Avastin can cost $100,000.
Some insurers already had quit covering the drug's use in breast cancer after FDA's advisers twice- once last year and once last summer- urged revoking the approval.
But Medicare said Friday that it will keep paying for now.

Decision maker: FDA Commissioner Margaret Hamburg announced the decision Friday after the severe side effects of the drug outweighed advantages

Medicare 'will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies,' said spokesman Don McLeod.
In 2008, the FDA allowed Avastin to be marketed as a treatment for breast cancer that has spread, or metastasized, to other parts of the body and is generally considered incurable.
The approval came under a special program that allows patients access to promising treatments while their makers finish the studies needed for final proof that they really work as promised.

When Avastin manufacturer Genentech did those studies, the data showed only a small effect on patients' tumor growth, not that they were living longer or had a better quality of life and not enough benefit to outweigh such severe side effects, FDA concluded.
Genentech, part of Swiss drug maker Roche Group, had argued that Avastin should remain available while it conducts more research to see if certain groups of patients might benefit from the drug.
Ms Hamburg encouraged Genentech do those studies
Roche and Genentech did not immediately comment Friday.

Enforcers: The FDA approves all drugs used legally in the U.S.
執法者：FDA批准所有在美國合法使用的藥物

http://www.dailymail.co.uk/news/article-2063323/FDA-pulls-use-breast-cancer-drug-Avastin-severe-effects.html

美ＦＤＡ：癌思停治乳癌無效 將撤許可
2010-12-18
中國時報
諶悠文、邱俐穎／綜合報導

　美國聯邦「食品暨藥物管理局」（ＦＤＡ）十六日表示，標靶藥物「癌思停」（Avastin，學名bevacizumab）無法有效治療乳癌，將撤銷其治療乳癌的許可；癌思停是國內當紅的標靶針劑藥物，衛生署食品藥物管理局表示，將收集相關資料後，召開藥品諮議小組進行療效評估。

　美國ＦＤＡ根據今年初該局諮詢委員會所做的決定說，癌思停注射劑會造成嚴重高血壓和出血等風險，而且無法延長女性乳癌患者整體存活期。ＦＤＡ並建議生產商瑞士「羅氏藥廠」（Roche）更改「癌思停」標示與仿單的適應症說明。在此同時，歐洲聯盟「歐洲藥品管理局」（ＥＭＡ）也建議限制「癌思停」只能與paclitaxel化療併用，而不是像現在的作法，搭配數種化療使用。

　ＦＤＡ發表聲明，建議刪除「癌思停」仿單所載適應症有關乳癌的部分，因為並無證據顯示這種抗癌藥對乳癌患者安全、有效，而且它還會帶來別的風險，包括鼻、胃和腸道等穿孔，以及心臟病發作或心臟衰竭。

　ＦＤＡ建議對於「癌思停」其他適應症，包括結腸癌、肺癌、腦癌及腎臟癌，則不構成影響。

　癌思停係透過抑制腫瘤血管新生，阻斷腫瘤養分供應，來抑制癌細胞生長，國內適用於轉移性大腸直腸癌、多型性神經膠母細胞瘤、轉移性乳癌及晚期的非小細胞肺癌四項適應症。

　台灣羅氏藥廠發言人蔡朝正表示，歐盟和美國看法不同，至今仍肯定「癌思停」醫療價值，目前藥廠傾向辦理公聽會，爭取保留乳癌適應症。　台灣乳房醫學會理事長俞志誠則表示，台灣今年六月才通過「癌思停」可用於轉移性乳癌，臨床上使用數量仍不算多，病人存活期及注射後的副作用尚不明顯，不過醫界也將密切注意美國的最後決議。

　抗癌藥「癌思停」目前尚未納入健保給付範圍，一劑約需自費一萬六，乳癌療程一次下來需自費十六到廿萬不等。
http://life.chinatimes.com/2009Cti/Channel/Life/life-article/0,5047,11051801+112010121800046,00.html


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