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Merck & Co Inc. (MRK) on Thursday said that Health Canada has granted approval of Keytruda as a monotherapy to treat patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours.This approval is based on the results from Phase II KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 studies.
默克公司(Merck&Co Inc.)周四表示,加拿大卫生部已批准Keytruda作为单一疗法,用于治疗不可切除或转移性微卫星不稳定性高(MSI-H)或错配修复缺陷(dMMR)实体瘤患者。该批准基于第二阶段KEYNOTE-158、KEYNOTE-164和KEYNOTE-051研究的结果。
The efficacy of Keytruda was investigated in 504 patients with MSI-H or dMMR cancer. In a pooled analysis for adult patients, Keytruda showed an objective response rate (ORR) of 34 percent, including a complete response rate of 11 percent and partial response rate of 23% percent..
在504例MSI-H或dMMR癌症患者中研究了Keytruda的疗效。在对成年患者的汇总分析中,Keytruda显示客观缓解率(ORR)为34%,其中完全缓解率为11%,部分缓解率为23%。。
Keytruda was first approved in 2014 and is currently used to treat various kinds of cancer across the world including head and neck squamous cell carcinoma, advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, etc.
Keytruda于2014年首次获得批准,目前用于治疗世界各地的各种癌症,包括头颈部鳞状细胞癌、晚期肾细胞癌、膀胱癌、非小细胞肺癌等。