美国食品和药物管理局批准Sarclisa作为新诊断的多发性骨髓瘤患者的第一线治疗, FDA approves Sarclisa as first-line treatment for newly diagnosed multiple myeloma patients unfit for transplant.

美国食品和药物管理局批准Sarclisa (伊萨图西马布) 作为新诊断多发性骨髓瘤的成年人的一线治疗,而这些成年人不能接受自身干细胞移植. The FDA has approved Sarclisa (isatuximab) as a first-line treatment for adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplant. 根据IMROZ第3阶段研究,Sarclisa与bortezomib、Lenalidomide和Dexamethasone(VRd)一道,仅与VRd相比,将疾病蔓延或死亡的风险降低了40%。 In combination with bortezomib, lenalidomide, and dexamethasone (VRd), Sarclisa reduced the risk of disease progression or death by 40% compared to VRd alone, based on the IMROZ phase 3 study. 这是Sarclisa在美国的第三个迹象, 也是对新诊断的病人的第一个迹象。 This marks Sarclisa's third indication in the U.S. and its first for newly diagnosed patients.