The US Food and Drug Administration accepted the supplemental Biologics License Application or sBLA for Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer.

美国食品和药物管理局接受Jemperli（dostarlimab）的补充生物制剂许可证申请或sBLA联合标准化疗（卡铂和紫杉醇），将治疗范围扩大到所有患有原发性晚期或复发性子宫内膜癌的成年患者。

It would include patients with mismatch repair proficient or MMRp/microsatellite stable or MSS tumours, GSK plc (GSK,GSK.L) said in a statement on Wednesday.Currently, Jemperli is FDA-approved in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 August 2024..

它将包括错配修复熟练或MMRp/微卫星稳定或MSS肿瘤的患者，GSK plc（GSK，GSK.L）周三在一份声明中表示。目前，Jemperli已被FDA批准与卡铂和紫杉醇联合使用，其次是Jemperli作为单一药物治疗成人原发性晚期或复发性子宫内膜癌患者，这些患者要么是错配修复缺陷型（dMMR），由FDA批准的测试确定，要么是微卫星不稳定性高（MSI-H）。FDA对该申请进行了优先审查，并指定了2024年8月23日的处方药用户费用法案行动日期。。

Jemperli?was discovered by AnaptysBio and licensed to TESARO, under a collaboration and exclusive license agreement signed in March 2014. Under the agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist.For More Such Health News, visit rttnews.com.

Jemperli？由AnaptysBio发现，并根据2014年3月签署的合作和独家许可协议授权给TESARO。根据该协议，GSK负责Jemperli和TIM-3拮抗剂cobolimab（GSK4069889）的持续研究，开发，商业化和制造。欲了解更多此类健康新闻，请访问rttnews.com。