LUMAKRAS™ (sotorasib) UPDATE

小安子同意了FDA的建议，在上市后开展一项比较960mg QD和每日低剂量的多中心随机对照研究，基于临床前、PK及临床数据，计划比较960mg QD 和 240mg QD，这项研究将在22年晚些时候开始不会影响LUMAKRAS™ (sotorasib) 的优先审评

THOUSAND OAKS, Calif., April 28, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it agreed last night with the FDA's proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower daily dose of the drug.  Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.

Amgen anticipates the results from the study in late 2022 and does not expect any impact on the timelines of the ongoing priority review of LUMAKRAS™.

但是惊悚的是，没有240mg啊 ，下图为CodeBreaK 100的结果：

https://investors.amgen.com/static-files/ec7417d1-ac9a-4195-b311-d7b04ed8c858

除了上面单独公告的低剂量临床，还提到治疗KRAS pG12Cm NACLC的PDUFA Date是8月16日，

其他管线可见链接

https://investors.amgen.com/static-files/11e21cfd-bd4e-4b99-8583-0ad21b2f5086