Monday, November 28, 2016 7:00 am EST

2016年11月30日讯 /生物谷BIOON/ --美国制药巨头默沙东（Merck & Co）免疫肿瘤学管线近日在美国监管方面传来喜讯。美国食品和药物管理局（FDA）已受理PD-1免疫疗法Keytruda（pembrolizumab）用于既往已接受治疗（经治）的晚期高微卫星不稳定性（microsatellite instability-high，MSI-H）癌症患者的补充生物制品许可（sBLA），FDA同时授予该sBLA优先审查资格，其处方药用户收费法（PDUFA）目标日期为2017年3月8日。之前，FDA已授予Keytruda治疗不可切除性或转移性MSI-H结直肠癌（colorectal cancer）的突破性药物资格；而就在最近，FDA还授予了Keytruda治疗不可切除性或转移性MSI-H非结直肠癌（non-colorectal cancer）的突破性药物资格。

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA^® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. The FDA granted Priority Review with a PDUFA, or target action date, of March 8, 2017; the sBLA will be reviewed under the FDA’s Accelerated Approval program based on tumor response rate and durability of response. The FDA recently granted Breakthrough Therapy Designation to KEYTRUDA for unresectable or metastatic MSI-H non-colorectal cancer, and previously granted it for the treatment of patients with unresectable or metastatic MSI-H colorectal cancer.

“The FDA’s acceptance of this application represents an important advance for the field of immuno-oncology and is further evidence of Merck’s commitment to identifying patients most likely to benefit from KEYTRUDA treatment,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We believe that patients whose tumors harbor DNA repair defects may be especially responsive to KEYTRUDA, and we look forward to working with the FDA to bring this important new therapy to these very challenging treatment situations.”