#PD-1
今日BMS宣布旗下Opdivo+Yervoy获FDA批准
即首个免疫抑制剂组合疗法
用于氟嘧啶、奥沙利铂和伊立替康治疗后疾病进展
微卫星高度不稳定/错配修复缺陷的转移性结直肠癌
(MSI-H/dMMR mCRC)
该决定基于临床试验CM-142
根据ORR和DOR加速审评获批
ORR: 46%
CR: 3.7%, PR: 43%
Metastatic colorectal cancers with dMMR or MSI-H biomarkers can be difficult to treat and some patients may need additional options. The FDA’s approval of an I-O/I-O combination provides us with an encouraging approach to address this challenging disease in patients who have progressed following treatment with three standard chemotherapy options.
——Heinz-Josef Lenz, M.D.
FACP, L. Terrence Lanni Chair in Gastrointestinal Cancer Research, Keck School of Medicine of University of Southern California and principal investigator of the study at USC Norris Comprehensive Cancer Center
Bristol-Myers Squibb is pleased to bring forward Opdivo plus Yervoy as the first I-O/I-O combination therapy to be approved in this type of colorectal cancer. Our commitment to studying Opdivo plus Yervoy, which target distinct but complementary immune pathways, results from our strong belief that rational combinations in biomarker-selected populations may improve clinical benefit for patients.
——Ian M. Waxman, M.D.
Development lead, gastrointestinal cancers, Bristol-Myers Squibb
去年Keytruda已经获批该适应症

另外
今天MSD旗下Keytruda经治的晚期肝癌sBLA
获得FDA优先审评资格
PDUFA日期2018.11.09
该决定依据为II期KN-224


There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma, which is the most common type of liver cancer. The data supporting our application provide a clear rationale for the advancement of the KEYTRUDA clinical program for hepatocellular carcinoma, and we are grateful for the opportunity to work with the FDA to potentially bring KEYTRUDA to patients living with this difficult-to-treat cancer.
——Dr. Scot Ebbinghaus
Vice president, clinical research, Merck Research Laboratories
而这也是Opdivo去年9月份获批的产品

始发于微信公众号: Pharmews