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GRANITE-001获得FDA快速通道指定用于治疗结直肠癌

2018-12-22 MedSci MedSci原创

GRANITE-001FDA快速通道指定
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Gritstone Oncology是一家临床阶段生物技术公司，致力于开发下一代癌症免疫疗法以对抗多种癌症，近日宣布GRANITE-001已经获得FDA快速通道指定用于治疗结直肠癌。

Gritstone Oncology是一家临床阶段生物技术公司，致力于开发下一代癌症免疫疗法以对抗多种癌症，近日宣布GRANITE-001已经获得FDA快速通道指定用于治疗结直肠癌。GRANITE-001是一种免疫疗法，含有患者特异性抗原，该抗原由Gritstone专有的EDGETM人工智能平台鉴定，是驱动肿瘤特异性T细胞攻击的最相关的新抗原。GRANITE-001与免疫检查点阻断剂联用疗法正在一项名为GO-004的I/II期临床研究中进行评估，该研究用于治疗常见的实体瘤，包括转移性非小细胞肺癌、微卫星稳定结直肠癌、胃食管癌和膀胱癌。

Gritstone Oncology的联合创始人，总裁兼首席执行官Andrew Allen博士说：“结肠直肠癌仍然是导致癌症死亡的主要因素，并且第一代免疫疗法对结肠直肠癌仍然效果不佳。我们相信GRANITE-001有可能通过其高度个性化的设计成为这些患者的有价值的治疗选择。在个体化免疫疗法的开发中，利用肿瘤标志物或新抗原特定于患者自身的肿瘤细胞已经成为了癌症治疗的下一个前沿”。美国食品和药物管理局授予快速通道指定，以促进发展并加快对治疗的审查，并有可能治疗严重疾病。接受快速通道指定的治疗剂可以从与该机构的早期和频繁通信中受益，目的是更快地向患者提供的新疗法。


原始出处：

http://www.firstwordpharma.com/node/1613078#axzz5aJrWexZu

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    2018-12-24 changfy

    #FDA快速通道指定#

    0

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    2018-12-24 qidongfanjian

    #快速通道指定#

    0

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    2018-12-24 crystal0564

    #结直肠#

    0

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    2018-12-23 lovetcm

    每一例患者都要设计，时间能不能来得及？将来价格会不会很吓人

    0