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FDA授予Exelixis公司抗癌药cabozantinib优先审查资格

2012-08-01 potato 生物谷

FDAExelixis公司cabozantinib优先审查
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Exelixis公司今天宣布，FDA已接受审查该公司抗癌药cabozantinib的新药申请（NDA），该药用于不能手术切除的恶性局部晚期或转移性髓样甲状腺癌（medullary thyroid cancer，MTC）的治疗。同时，FDA已授予该药优先审查资格（priority review designation），这意味着FDA将在6个月内完成cabozantinib NDA的审查。 在今年

Exelixis公司今天宣布，FDA已接受审查该公司抗癌药cabozantinib的新药申请（NDA），该药用于不能手术切除的恶性局部晚期或转移性髓样甲状腺癌（medullary thyroid cancer，MTC）的治疗。同时，FDA已授予该药优先审查资格（priority review designation），这意味着FDA将在6个月内完成cabozantinib NDA的审查。

在今年5月份，Exelixis向FDA提交了cabozantinib的新药申请，同时还向FDA提起优先审查申请。

临床前研究表明，cabozantinib通过靶向抑制MET、VEGFR2 及RET信号通路而发挥抗肿瘤作用，它能够杀死肿瘤细胞，减少转移并抑制血管生成。

Cabozantinib III期临床试验EXAM在FDA的特殊评估协议（SPA）下进行，以无进展生存期（PFS）为主要终末点。

2011年12月，Exelixis公布了EXAM研究结果，与安慰剂相比，cabozantinib使患者的中位无进展生存期增加了7.2个月，增至11.2月。

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    2012-08-03 sunylz

    #抗癌药#

    0

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    2012-08-03 yxch37

    #优先审查#

    0

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    2012-08-03 zhao4620

    #cabozantinib#

    0

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    2012-08-03 闆锋旦

    #ABO#

    0

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