美国食品药品监督管理局（FDA）已正式批准Kite制药对CAR-T细胞疗法Yescarta®（axicabtagene ciloleucel）进行标签更新，扩展其适应症范围至复发或难治性原发性中枢神经系统淋巴瘤（R/R PCNSL）的成年患者。这一重要监管决定标志着Yescarta®成为首款获批用于治疗该侵袭性血癌的CAR-T疗法，为缺乏有效治疗选择的患者群体提供了新的希望。
此次标签更新基于关键性II期ZUMA-31临床试验的积极数据。研究结果显示，Yescarta®在既往接受过多线治疗的患者中展现出显著且持久的临床缓解，其安全性与已知特征基本一致。这一里程碑式的批准不仅强化了Yescarta®在血液肿瘤治疗领域的领先地位，更凸显了细胞疗法在攻克难治性癌症方面的突破性潜力。
作为吉利德科学（Gilead Sciences）旗下全资子公司，Kite公司在细胞治疗领域的创新实力再次获得权威认可。此次适应症扩展将进一步提升Yescarta®的可及性，为更多面临治疗困境的淋巴瘤患者带来生命转机。
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