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大肠癌治疗药物Zaltrap获FDA批准

来源:环球医学编译    时间:2012年08月06日    点击数:    5星

8月6日消息--环球医学据悉,近日,美国食品和药物管理局(FDA)已批准用于治疗转移性大肠癌的药物Zaltrap ,该药物已由赛诺菲和Regeneron制药公司合作开发。

赛诺菲表示,Zaltrap可能对化疗无应答的大肠癌患者有效。大规模临床试验表明,接受Zaltrap联合 FOLFIRI化疗方案治疗的患者其生存期为13.5个月,而仅接受FOLFIRI化疗方案治疗的患者生存期为12个月。

分析师预测Zaltrap 将有$ 300万至$400万的最高年销售额,因此,Zaltra有望击败罗氏公司的阿瓦斯丁和施贵宝公司的Erbitux。“虽然近期我们预计Regeneron's的股票交易主要在给我们印象深刻的Eylea 投放市场,但是我们认为Zaltrap被批准是一件快速地证明生命技术可最好商业化的完美的补充,” RW Baird的分析师克里斯托弗•雷蒙德说。(环球医学)
 

原文

Sanofi’s Colorectal Cancer Drug Receives FDA Approval

 

Sanofi revealed that the US Food and Drug Administration has approved its metastatic colorectal cancer drug Zaltrap which has been developed in collaboration with Regeneron Pharmaceuticals.

The company said that Zaltrap could be effective in colorectal cancer patients who have not responded to chemotherapy treatment. Large scale clinical trials showed that people taking Zaltrap along with FOLFIRI chemotherapy combination regimen lived for 13.5 months compared to 12 months for those who received only FOLFIRI.

Zaltrap is expected to compete against Roche’s Avastin and Bristol-Myers Squibb’s Erbitux with analysts predicting that it could have peak annual sales of $300 million to $400 million. “While near-term we expect (Regeneron's) stock will continue to trade primarily on the Eylea launch which remains impressive, we view Zaltrap's approval as a nice complement to what is rapidly becoming one of biotech's best commercial stories”, RW Baird analyst Christopher Raymond said.

 

 

       原文链接:http://www.medindia.net/news/sanofis-colorectal-cancer-drug-receives-fda-approval-105095-1.htm

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