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LN-145获FDA突破性疗法认定用于治疗化疗期间或之后进展的晚期宫颈癌

2019-05-23 不详 网络

晚期宫颈癌LN-145突破性疗法认定
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Iovance是一家基于肿瘤浸润淋巴细胞（TIL）技术而开发新型癌症免疫疗法的生物技术公司，近日宣布，美国食品和药品监督管理局（FDA）授予了其候选药物LN-145的突破性疗法认定，以治疗化疗期间或之后进展的晚期宫颈癌患者。

Iovance是一家基于肿瘤浸润淋巴细胞（TIL）技术而开发新型癌症免疫疗法的生物技术公司，近日宣布，美国食品和药品监督管理局（FDA）授予了其候选药物LN-145的突破性疗法认定，以治疗化疗期间或之后进展的晚期宫颈癌患者。

Iovance总裁兼首席执行官评论道：“在化疗期间或之后进展的宫颈癌患者的治疗选择非常有限，我们希望尽快将LN-145带给这些患者。该指定使我们能够通过与FDA更频繁的互动来加快我们的发展计划，同时FDA提供了滚动审查和优先审查的资格”。FDA对LN-145的决定是基于正在进行的innovaTIL-04（C-145-04）试验的临床数据，该公司将于2019年6月1日在美国临床肿瘤学会（ASCO）年会上公布数据。


原始出处：

http://www.firstwordpharma.com/node/1642732#axzz5okQFj1Sv

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    2019-05-25 一闲

    #宫颈#

    0

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    2019-05-25 zhwj

    #突破性疗法#

    0

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    2019-05-25 ms7258648636991762

    #晚期宫颈癌#

    0

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    2019-05-24 lovetcm

    15年新轮回

    0

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