诺华(NVS.US)的镥 [177Lu] 特昔维匹肽上市申请获 CDE 受理

智通财经

2024-11-13

智通财经APP获悉，11 月 13 日，诺华(NVS.US)的镥 [177Lu] 特昔维匹肽上市申请获 CDE 受理。此前该药已被 CDE 纳入优先审评，适用于治疗前列腺特异性膜抗原（PSMA）阳性转移性去势抵抗性前列腺癌（mCRPC) 、已接受雄激素受体通路抑制和紫杉类化疗的成年患者。该药是 FDA 批准的首个针对去势抵抗性前列腺癌患者的靶向放射性配体疗法，本次是在国内首次报上市。

以放射配体疗法为代表的核药是诺华重金布局的领域。除了 Pluvicto，诺华还有一款核药 Lutathera 也已获批上市，用于生长抑素受体阳性（SSTR+）胃肠胰神经内分泌肿瘤成人患者，后又获批用于12 岁及以上儿童患者。Lutathera 2023 年销售额达 6.05 亿美元，2024 前三个季度销售额为 5.34 亿美元。

截图来源：CDE 官网

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