[1]https://www.cancernetwork.com/view/dostarlimab-gxly-granted-breakthrough-therapy-designation-for-rectal-cancer [2]https://us.gsk.com/en-us/media/press-releases/jemperli-dostarlimab-gxly-receives-us-fda-breakthro...
3.Powell MA, Hietanen S, Coleman RL, et al. Dostarlimab for primary advanced or recurrent (A/R) endometrial cancer (EC): outcomes by blinded independent central review (BICR) of the RUBY trial (ENGOT-EN6-NSGO/GOG-3031/RUBY)....
参考来源:‘Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer. News release. GSK plc. December 16, 2024. Accessed December 16, 2024.’ 香港登越药业温馨提示:本文旨在介绍医药健康研究,不作任何用药依据,具体用药指引,请咨询主治医师...
这项研究最初招募了30名II期或III期直肠癌患者，经免疫组织化学检查确认为dMMR，接受Dostarlimab持续治疗6个月。2022年ASCO年会公布了最初的数据：单药Dostarlimab-gxly(Jemperli，多塔利单抗)在14名II/III期错配修复缺陷(dMMR)局部晚期直肠癌患者中获得了100%的临床完全缓解(cCR)率，且无残留肿瘤证据!这项振...
FDA 已授予Jemperli (dostarlimab) 突破性疗法认定,用于治疗局部晚期错配修复缺陷 (dMMR)/微卫星不稳定性高 (MSI-H) 直肠癌患者。突破性疗法认定旨在加快开发和审查可能治疗严重疾病的药物,初步临床证据可能表明该药物比目前可用的疗法有显著改善。这是 dostarlimab 在局部晚期 dMMR/MSI-H 直肠癌中第二次获得...
Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer. News release. GSK plc. December 16, 2024. Accessed December 16, 2024. US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli (dostarlimab-gxly)...
2021年4月22日,美国食品药品监督管理局(FDA)加速了Dostarlimab-gxly(Jemperli)的批准,用于错配修复缺陷(dMMR)的复发或晚期子宫内膜癌的成年患者,这些患者在既往的含铂治疗方案中或之后疾病进展。 GARNET试验 在GARNET试验(clinicaltrials.gov;NCT02715284)中,根据队列A1评估了疗效,该试验是一项针对晚期实体瘤患者的...
FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy. FDA. August 1, 2024. Accessed December 16, 2024. Jemperli (dostarlimab) plus chemotherapy approved in the US as the first newfrontlinetreatment option in decades for dMMR/MSI-H primary advanced or recurrent endome...
Presented at: 2023 SGO Annual Meeting on Women’s Cancer; March 25-28, 2023; Tampa, Florida. FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer. News release. FDA. February 9, 2023. Accessed April 25, 2023. http://bit.ly/3xbGuH2...
Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer. News release. GSK plc. December 16, 2024. Accessed December 16, 2024. US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli (dostarlimab-gxly)...