我先给出Agios公司的官网5月15日发布的新闻介绍：

Agios Announces the Randomized Phase 3 ClarIDHy Trial of TIBSOVO? (ivosidenib) Achieved its Primary Endpoint in Previously Treated IDH1 Mutant Cholangiocarcinoma Patients?

seekingalpha.com

CAMBRIDGE, Mass., May 15, 2019 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the global Phase 3 ClarIDHy trial of TIBSOVO? (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation met its primary endpoint. Treatment with TIBSOVO? demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo. The safety profile observed in the study was consistent with previously published data.

A full analysis of the ClarIDHy trial will be submitted for presentation at the European Society for Medical Oncology Congress taking place in Barcelona, Spain from September 27-October 1, 2019. The company plans to submit a supplemental new drug application for TIBSOVO? in previously treated IDH1 mutant cholangiocarcinoma by the end of 2019.

这件事会产生以下的影响:

首先，FDA将会在2020年正式批准ivosidenib治疗IDH1突变驱动胆管癌。

其次， ivosidenib治疗IDH1突变驱动胆管癌将会在2020年底或2021年初进入NCCN指南。

最后， 等到ivosidenib进入中国市场， 不知道什么时候， 胆管癌测序进入中国指南，两者都实现以后ivosidenib治疗IDH1突变驱动胆管癌才会进入中国的指南，预期时间将至少是2022年以后。

从现在到2022年，而对于中国的胆管癌患者， 尤其是IDH1突变驱动的患者， 如果你不测序， 你永远不会知道有靶向药物可以治疗，国内几乎所有的医院在不测序的情况下都会按照下面的方案治疗， 乐伐替尼联合PD1抗体， 然后这个方案对于IDH1突变驱动的胆管癌患者根本就是无效的。知道这样的情况，患者该如何选择？

套用一句哈姆雷特的台词，「To be or not to be".

对胆管癌患者来说，测序与否，有时就是少活几个月的差别。

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