| <FONT size=4>FDA批准阿瓦斯汀（贝伐单抗）治疗多形性胶质母细胞瘤(GBM)，前提是标准治疗方法难以阻止此类脑癌的进展。</FONT>
<DIV><FONT size=4> GBM是一种快速进展的癌症，其能侵入脑组织并影响身体活动和精神能力。在美国，每年有大约6700名患者深受其害。经过手术、放疗和（或）化疗的初步治疗后，这种肿瘤几乎总可以复发。</FONT></DIV>
<DIV><FONT size=4> FDA药物评价和研究中心肿瘤药物产品办公室主任，Pazdur博士称：“这类癌症对目前的各种治疗有很强的耐受力，因此，这也是对治疗方法的挑战，而现在，阿瓦斯汀可以用来治疗那些对其他药物不敏感的侵袭性GBM了。”</FONT></DIV>
<DIV><FONT size=4> 阿瓦斯汀是一种实验室内生产的分子物质，也就是众所周知的单克隆抗体，它能够模拟机体免疫系统产生的抗体来抵御有害物质。这种药物能抑制血管内皮生长因子的作用，因为血管内皮生长因子能够促进新血管的形成，而新生血管可以营养肿瘤且促进肿瘤增长的同时也提供了一条通路，使癌细胞能进入体循环。</FONT></DIV>
<DIV><FONT size=4> 这种药物在2004年首次被批准可以用于结肠或直肠转移癌的治疗，此后又被批准用于非鳞化、非小细胞肺癌和转移性乳腺癌的治疗。</FONT></DIV>
<DIV><FONT size=4> 两个临床试验中有约25%的GBM病人对阿瓦斯汀有反应，平均的有效持续时间为4个月左右。</FONT></DIV>
<DIV><FONT size=4> 阿瓦斯汀最严重的副作用（这些副作用有时可以导致死亡）有胃肠穿孔、伤口愈合并发症、出血和血块形成。其他较严重的副作用有严重高血压、神经系统和视力障碍、白细胞计数降低、感染、中风、心肌梗死和肾脏问题。最常见的不良反应是鼻衄、头痛、高血压、流鼻涕、尿蛋白过量、味觉异常、皮肤干燥、直肠出血、泪液分泌过多和皮肤脱皮。</FONT></DIV>
<DIV><FONT size=4> 阿瓦斯汀由旧金山的Genentech公司生产。</FONT></DIV>
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<DIV><FONT size=2>原文</FONT></DIV>
<DIV><FONT size=2>FDA Approves Drug for Treatment of Aggressive Brain Cancer<!-- #EndEditable -->
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<P>The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. </P>
<P>GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities. It affects about 6,700 persons in the United States every year. Following initial treatment with surgery, radiation, and/or chemotherapy, the cancer nearly always returns.</P>
<P>“This type of cancer is very resistant to therapy and thus challenging to treat,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Avastin provides a therapy for patients with progressive GBM who have not responded to other medications.”</P>
<P>Avastin is a laboratory-produced molecule known as a monoclonal antibody that mimics the antibodies produced by the body’s immune system to defend against harmful substances. The medication inhibits the action of vascular endothelial growth factor that helps form new blood vessels. These vessels can feed a tumor, helping it to grow and can also provide a pathway for cancer cells to circulate in the body.</P>
<P>The drug was first approved in 2004 to treat metastatic cancer of the colon or rectum and has since been approved for treatment of non-squamous, non-small cell lung cancer and metastatic breast cancer.</P>
<P>In two clinical trials, about 25 percent of patients with GBM responded to Avastin with an average duration of response of about four months.</P>
<P>The most serious side effects associated with Avastin, in some cases resulting in death, are gastrointestinal perforation, wound healing complications, hemorrhage, and blood clots. Other serious side effects of Avastin are severe high blood pressure, nervous system and vision disturbances, decreased white blood cell counts, infection, stroke, myocardial infarction, and kidney problems.</P>
<P>The most common adverse reactions were nose bleeds, headache, high blood pressure, runny nose, excess proteins in the urine, taste alteration, dry skin, rectal bleeding, excessive tearing, and skin peeling.</P>
<P>Avastin is manufactured by Genentech Inc. of San Francisco.</P></FONT></DIV> |
