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年1月13日讯/生物谷BIOON/--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。（相关阅读：再立新功！施贵宝抗癌新药Opdivo成为第一个对肺癌有疗效的PD-1药物）

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。(生物谷Bioon.com）

原文 Merck to file its PD-1 inhibitor， hep C combo in US

Merck & Co is planning to hand in US applications for two of its flagship medicines in cancer and hepatitis C during the first half of this year.

The US drugmaker said today it intends to file its first-in-class cancer immunotherapy Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer patients (NSCLC) without ALK or EGFR mutations.

In September last year the drug became the first PD-1 inhibitor to win US Food and Drug Administration approval， as a treatment for advanced or unresectable melanoma.

The move sees the race to market heat up between Merck’s drug and Bristol-Myers Squibb’s rival PD-1 inhibitor Opdivo (nivolumab)， which is also already on the market for melanoma and boasted a strong set of lung cancer data over the weekend.

B-MS said a key Phase III trial pitting Opdivo against the chemotherapy docetaxel in previously-treated patients with advanced， squamous cell NSCLC was stopped early after the drug demonstrated a significant survival benefit.

The company noted that this is the first time a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer has been indicated. But analysts still believe that Keytruda will initially pull in the lion’s share of sales， given that its label is expected to cover more patients on launch， according to media reports.

Meanwhile， Merck also revealed at the 33rd Annual JP Morgan Healthcare Conference that it is seeking US clearance for a once-daily combination of grazoprevir and elbasvir as a treatment for hepatitis C.

PD-1也是需要基因检测么？

只能治疗无ALK或EGFR突变的？是否可以针对于肺腺？？

同问，有突变能用吗？肺腺癌能用吗？

有突变的可以吗