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2024年4月22日,ImmunityBio公司宣布,FDA已批准Anktiva(N-803)联合卡介苗(BCG),用于治疗卡介苗不响应的非肌层浸润性膀胱癌 (NMIBC) 伴原位癌 (CIS),伴或不伴乳头状瘤患者。该药物预计将于 2024 年 5 月中旬在美国上市。 关于N-803 N-803(nogapendekin alfa inbakicept-pmln)是一种白细胞介素-15(IL-15)...
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近日,ImmunityBio公司宣布,美国FDA授予其IL-15超级激动剂N-803突破性疗法认定,用于与卡介苗(BCG)联合治疗此前对BCG反应不佳的非肌层浸润性原位膀胱癌(CIS)患者。膀胱癌是一种常见的癌症。在全球范围内,每年大概有43万人被诊断出患有该疾病,使其成为全球第九大常见癌症。CIS是高级别的NMIBC原位癌,非肌层浸润性膀胱...
10月26日,ImmunityBio宣布FDA已接受其重新提交的N-803 BLA审查,PDUFA 日期设定为 2024 年 4 月 23 日。 N-803是一种IL-15超级激动剂,与卡介苗(BCG)联合用于治疗对卡介苗无反应的非肌层浸润性膀胱癌原位癌(CIS)。 N-803由 IL-15 突变体(IL-15N72D)与 IL-15 受体 α/IgG1 Fc 融合蛋白结合而成。版权...
NantKwest,Inc.(NK)联合ImmunityBio,Inc.,宣布了PD-l1t-haNK protocols的早期中期结果,显示,晚期转移性胰腺癌患者的中位生存率比其他FDA批准的治疗中位生存率高出一倍以上。这些试验基于最初的Cancer Moonshot hypothesis和2017年启动的exploratory QUILT试验,验证了一个理论,即通过协调自然杀伤细胞和T细胞治疗,无需大剂...
[1] ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer,Retrieved December 04, 2019, from https://www.businesswire.com/news/home/20191204005300/en [2] Preliminary phase 2 clinical results of IL-15R!Fc superagonist N-803 wit...
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