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GSK撤回肾癌药物帕唑帕尼用于卵巢癌的申请

发布时间:2014年04月03日 17:15:50

3月31日,葛兰素史克对一项后期试验数据进行分析之后,决定撤回其肾癌药物帕唑帕尼(Votrient)用于治疗晚期卵巢癌的申请,称试验数据不足以支持帕唑帕尼的这一适应症。葛兰素史克表示对此结果感到失望,此前帕唑帕尼的3期临床研究发现这款药物能改善卵巢癌患者的无进展生存期。

 

葛兰素史克早前在欧洲提交了帕唑帕尼用于晚期卵巢癌的上市申请,该公司称不会再向其它国家提交申请。帕唑帕尼作为一款治疗药物已被许多药品监管机构批准用于晚期肾癌及某些类型的肉瘤。

 

GSK pulls bid to extend use of kidney drug to ovarian cancer

 

GlaxoSmithKline on Monday withdrew an application to use Votrient, a drug licensed for kidney cancer, to treat advanced ovarian cancer after analysis of data from a late-stage trial did not support the benefit-to-risk ratio.

 

The British company said it was disappointed by the findings of the further analysis, which came after it found the drug caused an improvement in progression-free survival in its Phase III study.

 

GSK, which had applied for approval in Europe, said it would also not continue to develop the drug for advanced ovarian cancer in other countries.

 

Votrient, which has the chemical name pazopanib, has been approved by many regulators as a treatment for advanced kidney cancer and some types of soft cell sarcomas.

 

 

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