百时美施贵宝周一报告称，美国食品与药品管理局（FDA）已接受其Opdivo加Yervoy作为结直肠癌的潜在一线治疗选择的补充生物制品许可申请（sBLA）。

　　这种药物组合适用于患有不可切除或转移性结直肠癌的成人和12岁及以上儿童，这些结直肠癌具有高度微卫星不稳定性或错配修复缺陷。

　　该申请基于CheckMate-8HW 3期临床试验的分析，其中Opdivo联合Yervoy显示出优于Opdivo单药治疗和研究者选择的化疗的无进展生存期。

　　百时美施贵宝公司补充说，FDA已授予其申请突破性疗法认定和优先审评地位。它已将《处方药使用者费用法案》（PDUFA）的截止日期定为6月23日。

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