ImmunityBio(IBRX.US)淋巴细胞减少症疗法Anktiva获FDA扩大使用授权

智通财经
Jun 03, 2025

智通财经APP获悉,ImmunityBio(IBRX.US)周一表示,美国食品药品监督管理局(FDA)已批准其 Cancer BioShield 平台(包含 Anktiva)扩大使用范围,用于治疗患有晚期或复发性实体瘤的成人患者的淋巴细胞减少症,不论肿瘤类型如何。

该批准针对的是那些对化疗、放疗或免疫治疗等初始治疗无反应的患者。该扩大准入将面向所有一线治疗后病情未见好转且绝对淋巴细胞计数水平较低的实体瘤患者开放。

ImmunityBio 公司的 Anktiva 和 CAR-N 已获得美国食品药品监督管理局(FDA)的再生医学先进疗法认定,用于逆转接受化疗或放疗标准治疗的患者以及复发性局部晚期或转移性胰腺癌患者的淋巴细胞减少症。

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