美国食品药品监督管理局（FDA）已授予Seagen公司（纳斯达克代码：SGEN）提交的Padcev™（enfortumab vedotin-ejfv）联合默沙东Keytruda®（pembrolizumab）作为肌层浸润性膀胱癌患者围手术期治疗方案的补充生物制品许可申请优先审评资格。此项认定适用于所有符合条件的患者，无论其是否适合接受顺铂化疗。
优先审评意味着FDA将加速对该联合疗法申请的审评进程，旨在为存在高度未满足医疗需求的严重疾病提供潜在治疗选择。FDA预计将在2024年第二季度末做出审批决定。
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