Moderna与默沙东联合疗法获得FDA突破性疗法认定

智通财经2023-02-23

美国食品药品监督管理局(FDA)在近期授予Moderna旗下的个体化MRNA癌症疫苗MRNA -4157和默沙东V940联合Keytruda的突破性疗法认定，用于高危黑色素瘤患者完全切除手术后的辅助治疗。FDA的决定得到了被称为KEYNOTE-942/mRNA-4157-P201的2b期临床试验数据的支持。在这项研究中，与单独使用Keytruda相比，联合用药有助于将黑色素瘤(一种皮肤癌)患者的...

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Hoge表示:“mRNA-4157/V940联合KEYTRUDA在随机临床试验中首次证明了mRNA癌症治疗的有效性，并有可能成为治疗黑色素瘤和其他癌症的新前沿疗法。”两家公司指出，他们将继续与相关的监管部门讨论结果，并在2023年开始辅助性黑色素瘤疗法的3期试验，并扩展到其他肿瘤类型，包括非小细胞肺癌。","kind":"news","is_publish_news":true,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":1,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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