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【medical-news】对癌症药物优先批准 对结肠癌，直
New treatment for colon, rectal cases to be made in Fremont
Bernadette Tansey, Chronicle Staff Writer
The Food and Drug Administration said Wednesday that it has approved a new colon cancer drug, Vectibix, developed by Amgen and Abgenix, the Fremont company it recently acquired.
Vectibix, a monoclonal antibody with the generic name panitumumab, is rated by analysts as a potential blockbuster drug that will compete with Erbitux, which was developed by ImClone Systems.
Both drugs target the same cancer cell receptor, EGFR, which has been tied to tumor growth. The FDA estimates that 150,000 new cases of colon and rectal cancer will be diagnosed in 2006, with 55,000 deaths caused by the disease. About 70 percent of those cancers have tested positive for EGFR.
The FDA granted Vectibix a priority approval process based on clinical trial findings that the drug slowed the advance of colon cancer among subjects with metastatic cancer who were no longer benefiting from chemotherapy.
Although the drug delayed the progress of the disease in these very sick patients, and in some cases shrank their tumors, studies have not yet proven that Vectibix extends life.
As a condition of the FDA approval, Amgen will conduct trials to determine whether Vectibix can improve survival rates if given earlier in the treatment.
Vectibix, which Amgen of Thousand Oaks (Ventura County) acquired when it purchased Abgenix, is Amgen's first drug to treat cancer directly. Although Amgen is the world's largest oncology company with $12.4 billion in 2005 revenue, its top sellers are drugs like Aranesp that treat conditions related to cancer. Aranesp is prescribed for anemia induced by chemotherapy.
Amgen's price for Vectibix will be $8,000 a month, or about $16,000 for a typical two-month course of treatment, said Cynthia Schwalm, vice president and general manager in oncology.
The company said it has set up a comprehensive financial assistance program to help U.S. patients pay for the drug. Co-payments will be capped at 5 percent of patients' adjusted gross income. In addition, Amgen said it set the price for Vectibix at 20 percent less than the price for Erbitux.
Amgen shares rose $1.39, nearly 2 percent, to close at $72.14 Tuesday. They gained an additional 6 cents in after-hours trading. ImClone shares dropped 69 cents, or 2.34 percent, to close at $28.75. They dropped an additional 97 cents after hours.
Vectibix will be manufactured at Amgen's Fremont plant, where the workforce of 320 will be expanded to about 370 by the end of 2006. 认领之 The Food and Drug Administration said Wednesday that it has approved a new colon cancer drug, Vectibix, developed by Amgen and Abgenix, the Fremont company it recently acquired.
FDA星期三声称，它已批准了一种新的结肠癌药物Vectibix。位于Fremont的Amgen &Abgenix公司最近获得了这种药物（的所有权）。
Vectibix, a monoclonal antibody with the generic name panitumumab, is rated by analysts as a potential blockbuster drug that will compete with Erbitux, which was developed by ImClone Systems.
Vectibix是一种单克隆抗体，通用名为panitumuma。业内分析家认为这种药物是一种潜在的威力巨大的药物，可与Erbitux媲美，后者是由ImClone Systems研发得来。
Both drugs target the same cancer cell receptor, EGFR, which has been tied to tumor growth. The FDA estimates that 150,000 new cases of colon and rectal cancer will be diagnosed in 2006, with 55,000 deaths caused by the disease. About 70 percent of those cancers have tested positive for EGFR.
这两种药物针对的是同样癌细胞受体，EGFR。该受体与肿瘤的生长有关。FDA估计2006年有150000起结肠和直肠癌的新发病例，并导致55000例死亡。这些癌症病例大约有70%经检测发现有EGFR阳性。
The FDA granted Vectibix a priority approval process based on clinical trial findings that the drug slowed the advance of colon cancer among subjects with metastatic cancer who were no longer benefiting from chemotherapy.
FDA允许Vectibix进入优先批准程序是基于临床试验中的发现。试验中在治疗那些伴有转移已不能从化疗中获益的结肠癌患者时，这种药物具有一定的优越性。
Although the drug delayed the progress of the disease in these very sick patients, and in some cases shrank their tumors, studies have not yet proven that Vectibix extends life.
尽管药物在一些存在严重呕吐症状的病人中延缓了疾病的进展，在一些病例中还使肿瘤缩小，但研究还未能证明Vectibix可延长患者的生命。
As a condition of the FDA approval, Amgen will conduct trials to determine whether Vectibix can improve survival rates if given earlier in the treatment.
作为FDA批准的一个附带条件，Amgen将进行一些试验验证Vectibix在病情发展早期给药治疗是否能改善生存率。
Vectibix, which Amgen of Thousand Oaks (Ventura County) acquired when it purchased Abgenix, is Amgen's first drug to treat cancer directly. Although Amgen is the world's largest oncology company with $12.4 billion in 2005 revenue, its top sellers are drugs like Aranesp that treat conditions related to cancer. Aranesp is prescribed for anemia induced by chemotherapy.
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作者:admin@医学,生命科学 2011-01-23 05:14
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