Genasense Approval Delayed Again

April Astor

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Genasense Approval Delayed Again

机译：Genasense审批再次延迟

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The FDA has decided the available data for leukemia drag Genesense are not adequate to support approval of the drug, which is designed for relapsed or refractory chronic lymphocytic leukemia. In response to an appeal filed by drugmak-er Genta last October, CDER acknowledged the primary endpoint in the pivotal trial was appropriate for assessing efficacy, Genta said. The FDA also agreed that this endpoint was achieved and that those results supported the efficacy of the drug. However, CDER concluded there was insufficient "confirmatory evidence" in the NDA to approve Genasense (oblimersen sodium).

机译：FDA认为Genesense对白血病药物的可用数据不足以支持该药的批准，该药是针对复发性或难治性慢性淋巴细胞性白血病而设计的。 Genta说，在回应Drugmak-er Genta去年10月提出的上诉时，CDER承认关键试验的主要终点指标适合评估疗效。 FDA还同意达到这一终点，并且这些结果支持了该药物的功效。但是，CDER得出结论，NDA中没有足够的“确证”来批准Genasense（奥伯利森钠）。

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《Washington Drug Letter》 |2008年第12期|p.12|共1页
作者
April Astor;
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正文语种 eng
中图分类生物科学;
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Genasense Approval Delayed Again

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