林业发展局批准Breyanzi CAR T疗法,以治疗经两次治疗后复发/复发性边缘性淋巴瘤。 FDA approves Breyanzi CAR T therapy for relapsed/refractory marginal zone lymphoma after two prior treatments.

林业发展局核准了Breyanzi,即CAR T细胞疗法,用于治疗至少曾接受过两次治疗的复发或复发性边缘淋巴瘤的成年人。 The FDA has approved Breyanzi, a CAR T-cell therapy, for adults with relapsed or refractory marginal zone lymphoma who have had at least two prior treatments. 根据66个病人的试验数据,它显示总体答复率为95.5%,完整答复率为62.1%,答复平均至少持续21.6个月。 Based on trial data from 66 patients, it showed a 95.5% overall response rate and 62.1% complete response rate, with responses lasting at least 21.6 months on average. 治疗出自病人自己的T细胞,在淋巴衰竭后进行,并具有安全特征,包括细胞释放综合症和神经疾病。 The therapy, derived from a patient’s own T cells, is administered after lymphodepletion and has a safety profile including cytokine release syndrome and neurologic events. 它由大多数保险计划覆盖,并支持住院和门诊使用。 It is covered by most insurance plans and supports both inpatient and outpatient use. 这标志着CAR T首次批准MZL, 这是美国罕见的淋巴瘤, 每年约有7500例新病例。 This marks the first CAR T approval for MZL, a rare lymphoma with about 7,500 new cases annually in the U.S.