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【drug-news】FDA批准治疗皮肤癌的新药Zolinza 2006-
FDA News
FOR IMMEDIATE RELEASE
P06-162
October 6, 2006
Media Inquiries:
Megan Moynahan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
The U.S. Food and Drug Administration (FDA) today approved Zolinza (vorinostat) capsules for the treatment of cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines.
Zolinza was approved as part of FDA's Orphan Drug program, which offers companies financial incentives to develop medications for diseases affecting fewer than 200,000 American patients a year. Every year in the United States, about three in every one million people are diagnosed with CTCL. The majority of people with CTCL are men with an average age of 50 years.
"This approval is another example of the benefits of modern research that's focused on providing prescribers with safe and effective therapies for all types of cancer, including those that affect relatively few patients," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.
Evidence of Zolinza's safety and effectiveness was developed in two clinical trials with 107 CTCL patients who received Zolinza after their disease had recurred following other treatments. A response, defined by improvements on a scale that scores skin lesions, occurred in 30 percent of patients who received Zolinza and lasted an average of 168 days. The most common serious adverse events were pulmonary embolism (blood clot in the lungs), dehydration, deep vein thrombosis and anemia. The most common other adverse events were gastrointestinal symptoms (including diarrhea, nausea, anorexia, vomiting and constipation); fatigue; chills; and taste disorders.
Zolinza has not been studied in pregnant women, but results of animal studies suggest that the drug may cause fetal harm when administered during pregnancy.
Zolinza is manufactured by Pantheon, Inc., in Mississauga, Ontario, Canada, for Merck & Co., Inc., Whitehouse Station, N.J.
美国FDA于10月6日批准了Zolinza（vorinostat）胶囊用于治疗一种叫皮肤T细胞淋巴瘤（CTCL）的皮肤癌，通常用于其他药物治疗效果不佳，甚至病情恶化，反复的病例。
Zolinza作为美国FDA“孤儿药”（罕见病药物）项目的一部分被批准，该项目每年主要由政府出资来吸引药厂研发一些药物，来治疗患病人群数每年低于20万的罕见病症。而在美国，每年每一百万人里大约有3人被诊断出CTCL。他们大多数是男性，平均年龄为50岁。
FDA药物评估研究中心的主任Steven Galson 医学博士说：“此次批准又是一得益于当前开发模式的例子，该模式着力于针对所有癌症向开方医师提供一个安全有效的治疗方案，其中包括那些患者人数很少的癌症”。
Zolinza的安全有效性数据是从两个107个CTCL患者样本的临床试验中得出的，这些使用Zolinza的病人曾接受过其他药物治疗但病情反复。通过皮肤损伤程度的标记评分来衡量症状的改善，结果30%接受Zolinza并平均持续使用了168天的病人观察到有效。最常见的严重不良反应是肺部栓塞（肺有血凝块），脱水，深静脉血栓和贫血。其他常见的不良反应还有胃肠系统的症状（包括腹泻、恶心、厌食、呕吐以及便秘）； 疲劳感；寒战；味觉改变。
Zolinza用于孕妇还没有研究，但相关的动物实验结果提示在妊娠期间服药可能造成致命的损害。
Zolinza由加拿大位于安大略湖的米西索加的Pantheon为默克公司生产。 http://www.dxy.cn/bbs/post/view?bid=116&id=7221256&tpg=1&ppg=1&sty=0&age=30#7221256 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-08-05 06:23
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