PD-1市场硝烟再起，默沙东将向FDA提交Keytruda肺癌适应症审批申请

2015-01-14 佚名生物谷

2015年伊始，默沙东打算向FDA提交两款肿瘤和丙肝新药的审批申请，打响2015年的第一仗。去年9月，Keytruda (pembrolizumab)成为首个获FDA批准的PD-1抑制剂，用于治疗晚期的、不可切除的黑色素瘤。默沙东近日宣布，其用于治疗非小细胞肺癌（无ALK或EGFR突变）肿瘤免疫疗法Keytruda (pembrolizumab)将提交FDA批准。此番动作势必会点燃与百

2015年伊始，默沙东打算向FDA提交两款肿瘤和丙肝新药的审批申请，打响2015年的第一仗。

去年9月，Keytruda (pembrolizumab)成为首个获FDA批准的PD-1抑制剂，用于治疗晚期的、不可切除的黑色素瘤。默沙东近日宣布，其用于治疗非小细胞肺癌（无ALK或EGFR突变）肿瘤免疫疗法Keytruda (pembrolizumab)将提交FDA批准。

此番动作势必会点燃与百时美施贵宝的战火，百时美的PD-1抑制剂Opdivo (nivolumab)也已上市，同样是用于治疗黑色素瘤。

百时美日前发布了Opdivo的三期临床试验数据，结果表明与化疗药物多烯紫杉醇对照，Opdivo使得鳞状细胞非小细胞肺癌患者的生存率明显上升，具有极高的应用前景，并且日前也已向FDA提交了该药治疗肺癌适应症的申请，获批的可能性非常大。

尽管百时美施贵宝表示Opdivo是首个证明治疗肺癌有效的PD-1抑制剂，但也有评论认为，Keytruda会在PD-1抑制剂的市场上占得相当的优势。

与此同时，默沙东在第33届JP Morgan医疗年会上宣布，将会申请批准grazoprevir 与elbasvir联合治疗，作为治疗丙肝的新模式。

PD-1抑制剂已是诸多制药巨头拼力争夺的巨大市场，百时美和默沙东的市场争夺战才刚刚揭开帷幕，敬请期待好戏上演。

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2015-01-16 yese

#默沙东#

24 0
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2015-01-16 644982816_68283321

#适应症#

23 0
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2015-01-14 223.104.5.**

下一步主要研究最佳应用时机。如作为二线治疗，还是维持治疗?能否用于一线，如果用于一线治疗，如何与化疗或者靶向配合?进一步有没有可能用于新辅助治疗?大约10年时间能完整回答这些答案。

133 0
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2015-01-14 223.104.5.**

肿瘤免疫治疗将来可以覆盖大部分肿瘤。因为它作用于肿瘤免疫耐受和免疫逃避关键要害

112 0

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