礼来制药与信达生物深化肿瘤领域合作
佚独丶
发表于 2024-12-16 19:14:55
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匹妥布替尼于2023年1月获得美国FDA批准,成为全球首个且唯一获批的非共价(可逆)BTK抑制剂。
在中国,匹妥布替尼于2024年10月获得国家药品监督管理局(NMPA)批准,单药适用于既往接受过至少两种系统性治疗(含BTK抑制剂)的复发或难治性套细胞淋巴瘤(MCL)成人患者。
礼来正在全球(包括中国)开展多项匹妥布替尼的3期临床研究,包括初治及复发/难治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)的和未经BTK抑制剂治疗的复发/难治MCL等,探索单药或联合治疗的潜力。
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