FDA批准Eli Lilly的Jaypirca治疗先前使用BTK抑制剂治疗的某些白血病和淋巴瘤病人。 FDA approves Eli Lilly’s Jaypirca for certain leukemia and lymphoma patients previously treated with BTK inhibitors.

美国食品和药物管理局已批准Eli Lilly的Jaypirca (pirtobrutinib) 作为传统药物,用于治疗复发性或耐药性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤的成年人,这些成年人之前曾接受过共价BTK抑制剂. The FDA has granted traditional approval to Eli Lilly’s Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received a covalent BTK inhibitor. 这将其使用扩大到早期治疗阶段,并随后得到初步加速批准。 This expands its use to earlier treatment stages and follows an initial accelerated approval. 批准的依据是BRUIN-CLL-321试验,显示中位无累进性存活率为11.2个月,而控制组为8.7个月,危险比率为0.58。 The approval is based on the BRUIN-CLL-321 trial, showing a median progression-free survival of 11.2 months versus 8.7 months in the control group, with a hazard ratio of 0.58. Pirtobrutinib(一种非covalent BTK抑制剂)为抗或不容忍现有BTK抑制剂的病人提供了新的选择。 Pirtobrutinib, a non-covalent BTK inhibitor, offers a new option for patients resistant to or intolerant of existing BTK inhibitors. 每天口服剂量为200毫克,对感染、出血、低血数、心脏节奏问题、二级癌症、肝损伤和胎儿伤害发出警告。 It is taken orally at 200 mg once daily, with warnings for infections, bleeding, low blood counts, heart rhythm issues, secondary cancers, liver damage, and fetal harm.