默沙东(MRK.US)“first-in-class”小分子药物获欧盟批准两项适应症

智通财经
19 Feb

智通财经APP获悉,默沙东(MRK.US)公司今天宣布,欧盟委员会已有条件批准其口服低氧诱导因子2α(HIF-2α)抑制剂Welireg(belzutifan)上市,作为单药治疗下列适应症:

von Hippel-Lindau(VHL)病成人患者,他们携带不适合手术,需要治疗的局部肾细胞癌(RCC)、中枢神经系统(CNS)血管母细胞瘤或胰腺神经内分泌肿瘤(pNET)。

接受过两线或以上治疗方案(其中包含PD-1或PD-L1抑制剂及至少两种血管内皮生长因子靶向治疗)后疾病进展的成人晚期透明细胞RCC患者。

新闻稿指出,Welireg是欧盟批准的首个HIF-2α抑制剂,也是治疗VHL病相关肿瘤的首个全身性治疗药物。

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