Keytruda再获优先审评，宫颈癌适应症有望在6月28日批准上市

（作者：Pista，转自：pharmews）

#PD-1

近日来自MSD的Keytruda

其sBLA获得FDA优先审评资格

适应症为化疗中/化疗后进展的晚期宫颈癌

这为第一个

FDA接收的用于宫颈癌的PD-1抑制剂上市申请

也是第一个

获得优先审评资格用于宫颈癌的PD-1抑制剂申请

另外这已经是Keytruda第14个上市申请了

该申请基于Keynote-158临床II期试验

PDUFA为2018年6月28日

2015年12月启动

200 mg Q3W

首要研究终点为ORR

去年ASCO公布的KN-158初期分析结果

首批47名受试者的ORR为17%

其中有87%位受试者为PD-L1阳性

当然在宫颈癌方面

免疫抑制剂的临床研究并不止Keytruda

还有更多

除了这一些以外

还有更多的联用临床

包括此前的那一篇报道中的GX-188E

联用也许可以提高单药的ORR

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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) has accepted a new supplemental Biologics License Application (sBLA) and granted Priority Review for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy. The application is seeking approval for KEYTRUDA as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy. This is the first filing acceptance and Priority Review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for KEYTRUDA. The FDA has set a PDUFA, or target action, date of June 28, 2018.

“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need. We look forward to working with the FDA on the review of this application to help bring KEYTRUDA to previously-treated patients with advanced cervical cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.

The application, which is seeking accelerated approval for this new indication, is 48 30590 48 14942 0 0 1628 0 0:00:18 0:00:09 0:00:09 2895based in part on data from the phase 2 KEYNOTE-158 trial. KEYNOTE-158 is an ongoing global, open-label, non-randomized, multi-cohort, multi-center study evaluating KEYTRUDA in patients with multiple types of advanced solid tumors – including cervical cancer – that have progressed on standard of care therapy.

Merck is executing an extensive clinical development program in a broad range of cancers that affect women. To date, the program includes numerous studies evaluating KEYTRUDA (pembrolizumab) as monotherapy or in combination with other anti-cancer treatments across various types of breast and gynecological cancers.

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