美国食品和药物管理局批准RMAT用于CAR-T治疗P-BCMA-ALL01复发/耐药多发性骨髓瘤,反应率为82%. FDA grants RMAT to CAR-T therapy P-BCMA-ALL01 for relapsed/refractory multiple myeloma with 82% response rate.

根据早期试验数据显示总体响应率为82%,FDA已授予P-BCMA-ALL01的RMAT名称,该药物是针对复发性/耐药性多发性骨髓瘤的试验性CAR-T疗法. The FDA has awarded RMAT designation to P-BCMA-ALL01, an investigational CAR-T therapy for relapsed/refractory multiple myeloma, based on early trial data showing an 82% overall response rate. 治疗没有显示移植对宿主疾病,CRS和神经毒性率低. The therapy demonstrated no graft-vs-host disease and low rates of CRS and neurotoxicity. 此外,ESMO 2024专家的见解突出了CAR-T和双特异性疗法的进展,为治疗选择有限的患者提供了新的希望. Additionally, insights from experts at ESMO 2024 highlight advancements in CAR-T and bispecific therapies, offering new hope for patients with limited treatment options.