FDA正式撤销罗氏制药安维汀的乳腺癌治疗许可

蓝鱼o_0

FDA Commissioner Removes Breast Cancer Indication from Avastin LabelFDA Commissioner Margaret Hamburg is revoking the agency’s accelerated approval of the breast cancer indication for Avastin (bevacizumab), manufactured by Genentech.   Avastin used for metastatic breast cancer has not been shown to provide a benefit, in terms of delay in the growth of tumors, that would justify its serious and potentially life-threatening risks. Nor is there evidence that use of Avastin will either help women with breast cancer live longer or improve their quality of life.
Today's decision involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin's product labeling.
Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).
Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.
After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.
FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.  Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That hearing took place June 28-29, 2011.
Dr. Hamburg has now made her decision based on a review of the arguments and evidence presented at the hearing, briefs filed by both CDER and Genentech before and after the hearing, public comments and data from multiple clinical trials.



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