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下面是一篇最近的Urological Review的文章, 介绍Sorafenib Tosylate在美国和瑞士批准上市的消息,目前澳大利亚正在审核公司的上市申请,但应该在这里还没有出售.该药是拜耳和Onyx公司推出的治疗的晚期肾癌药，是目前世界上首个口服多激酶抑制剂，靶向作用于肿瘤细胞及血管激酶，她既然可以阻止细胞增生，又作用于VEGFR-2/ PDGFR-β，阻止肿瘤血管生成的药物。已有的临床实验证实它不仅能在控制病情的情况下使患者的生存时间翻倍,同时它的毒性比其他的同类药物（如干扰素等）也小得多，而且它为口服药物，与注射剂相比对患者更有益。
Nexavar Approved In Switzerland For The Treatment Of Patients With Advanced Kidney Cancer ( 30 March 2006)
WEST HAVEN, Conn. and EMERYVILLE, Calif., March 30 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Nexavar(R) (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN). - First European Approval in New Class of Cancer Therapy -
WEST HAVEN, Conn. and EMERYVILLE, Calif., March 30 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Nexavar(R) (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN). Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in Switzerland.
"The approval of Nexavar in Switzerland marks an important step in the brand's entry into Europe. We are pleased with the decision by Swissmedic, and proud that we can now make this therapy available to physicians and patients in this region," said Dr. Gunnar Riemann, Head of Bayer HealthCare's Pharmaceuticals Division.
Nexavar was approved by the U.S. Food and Drug Administration (FDA) in December 2005. In September 2005, Bayer filed for regulatory approval with the European Medicines Agency (EMEA). Pending a favorable review, market availability is possible in the EU countries in the second half of 2006. In addition, Bayer has completed filings in several countries, including Mexico, Australia, Brazil, Canada, and Turkey.
About Nexavar
Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.
Nexavar has been studied in more than 20 tumor types and in nearly 8,000 clinical trial patients. It is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer. A Phase III clinical trial in non-small cell lung cancer (NSCLC) was initiated in February 2006. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators. |
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我的第三次创业---海运拼柜团购网454楼 (2010-7-15) 老顽童 
发表于 2006-9-4 20:42
