美国食品和药物管理局拒绝Replimune的黑色素瘤药RP1由于缺乏有效性. FDA rejects Replimune's melanoma drug RP1 for lack of effectiveness.

美国食品和药物管理局第二次拒绝Replimune集团的实验性黑色素瘤药物RP1,理由是缺乏有效证据. The U.S. Food and Drug Administration has rejected Replimune Group’s experimental melanoma drug, RP1, for the second time, citing insufficient evidence of effectiveness. 监管机构表示,包括额外分析在内的最新临床试验数据未能证明晚期皮肤黑色素瘤患者的实质性益处. Regulators stated that the latest clinical trial data, including additional analyses, failed to demonstrate substantial benefit for patients with advanced cutaneous melanoma. 该机构强调了研究设计和无法分离药物的特定贡献的持续担忧. The agency highlighted ongoing concerns regarding the study's design and the inability to isolate the drug's specific contribution. 雷普利蒙股价在宣布后下跌近20%. Replimune’s stock dropped nearly 20% following the announcement.