智通财经APP获悉，艾伯维(ABBV.US)宣布美国FDA已经批准其ADC疗法Pivekimab sunirine(PVEK)上市，用于治疗母细胞性浆细胞样树突细胞肿瘤(BPDCN)。资料显示，这是全球首个获批上市的CD123 ADC，也是艾伯维首个获批的血液瘤ADC。
据悉，BPDCN 是一类兼具白血病与淋巴瘤特征的高度侵袭性罕见血液恶性肿瘤，患者通常会出现皮肤病变，病情还易扩散至骨髓、中枢神经系统及淋巴结。目前临床标准一线方案以高强度化疗为主，部分患者后续需接受干细胞移植，但整体治疗选择有限。无论是初治患者，还是化疗后复发、难治的患者，均存在巨大的未满足临床需求，亟需安全性与疗效更优的创新靶向药物。
Pivekimab sunirine是一款靶向CD123的ADC，拟开发用于治疗血液系统恶性肿瘤。CD123靶点在BPDCN肿瘤细胞中呈高度特异性高表达，是该病理想的治疗靶点。美国FDA已于2020年10月授予该药物BPDCN适应症突破性疗法认定。本次FDA获批主要基于全球多中心I/II 期CADENZA临床试验的数据，研究主要终点为复合完全缓解率(CR+CRc)。
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