Iressa discontinued in U.S.

2005年。

FDA has carefully reviewed data from two failed clinical studies of Iressa, one of which was required by the agency as part of the drug’s accelerated approval. This trial enrolled patients with regionally advanced or metastatic NSCLC who had failed one or two prior treatment regimens. In this large study, 1,692 patients were randomized to gefitinib or placebo. There was no significant survival benefit in the overall study population nor in patients who had high levels of a surface marker called “EGFR”. In contrast, the presence of EGFR at high levels appears to predict a good response to Tarceva.

In the second trial in patients with stage III NSCLC, after completion of induction and consolidation chemotherapy and radiation therapy, patients were randomized to Iressa or placebo maintenance therapy. No Iressa survival benefit could be demonstrated.

The Food and Drug Administration is not considering market withdrawal of Iressa at this time. New clinical trials are being developed, other ongoing trials are being completed, and there will be further analysis of the completed trials described above. These will determine the future role of Iressa treatment.

http://www.fda.gov/Drugs/DrugSaf ... onals/ucm085197.htm

2007年阿斯利康宣布易瑞沙退出美国市场。

（这个消息竟然现在才知道，真失败）

不足为奇，基因差异