1月6日，百济神州宣布，其自研的1类新药新型BCL2抑制剂百悦达®（索托克拉片）获得国家药品监督管理局附条件批准，用于治疗既往接受过至少包含布鲁顿酪氨酸激酶（BTK）抑制剂在内的一种系统治疗的慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）成人患者，以及既往接受过至少两种系统性治疗（含布鲁顿酪氨酸激酶[BTK]抑制剂）的复发或难治性套细胞淋巴瘤（MCL）成人患者。
基于此次获批，索托克拉将为已接受过BTK抑制剂治疗的CLL/SLL患者带来新的治疗选择，更使其成为国内首款且唯一可用于治疗MCL的BCL2抑制剂。这两项适应症的上市申请此前被NMPA药品审评中心（CDE）纳入优先审评程序。
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