ImmunityBio, Inc. (简称ImmunityBio) 宣布，美国食品药品监督管理局(FDA)已受理其关于Anktiva® (nogapendekin alfa inbakicept) 联合卡介苗(BCG)用于治疗BCG无应答、伴乳头状病变的非肌层浸润性膀胱癌(NMIBC)患者的补充生物制品许可申请(sBLA)。FDA同时为该申请设定了处方药用户付费法案(PDUFA)目标日期——2027年1月6日。
此次sBLA的提交基于一项关键性2/3期临床试验的积极数据。该研究评估了Anktiva联合BCG在BCG无应答NMIBC患者中的疗效与安全性。数据显示，该联合疗法显著提高了患者的完全缓解率，并展现出良好的耐受性。
若获得批准，Anktiva联合BCG将为这一治疗选择有限的患者群体提供一个重要的新治疗选项。PDUFA日期标志着FDA完成审评的目标时间点，但最终决定可能早于或晚于该日期。
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