10月20日(周一),Summit Therapeutics宣布计划于第四季度向FDA提交其与康方生物合作的PD-1/VEGF双抗依沃西单抗的上市申请。尽管此前FDA反馈,统计学意义显著的总生存期(OS)数据可能是必须的,但该公司仍坚持基于HARMONi试验PFS获益48%的积极结果提交申请。该举措基于对III期HARMONi试验结果的审查后做出。在该试验中,依沃西单抗联合化疗,在既往接受过...
Source Link10月20日(周一),Summit Therapeutics宣布计划于第四季度向FDA提交其与康方生物合作的PD-1/VEGF双抗依沃西单抗的上市申请。尽管此前FDA反馈,统计学意义显著的总生存期(OS)数据可能是必须的,但该公司仍坚持基于HARMONi试验PFS获益48%的积极结果提交申请。该举措基于对III期HARMONi试验结果的审查后做出。在该试验中,依沃西单抗联合化疗,在既往接受过...
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