Replimune Group Inc. 宣布，美国食品药品监督管理局（FDA）已正式受理其针对候选疗法RP1用于治疗晚期黑色素瘤的生物制品许可申请（BLA）的重新提交。
此次受理标志着该公司在推进这一溶瘤病毒免疫疗法上市进程中迈出了关键一步。FDA设定的处方药用户费用法案（PDUFA）目标审评日期为2024年12月25日。
该BLA的提交主要基于关键的CERPASS临床试验数据，该研究评估了RP1与抗PD-1疗法利博利单抗联合使用，相较于单独使用利博利单抗，在晚期黑色素瘤患者中的疗效与安全性。
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