FDA批准Sanofi's Sarclisa一线治疗新诊断的多眼瘤。 FDA approves Sanofi's Sarclisa for first-line treatment of newly diagnosed multiple myeloma.

美国食品和药物管理局批准了赛诺菲的Sarclisa (西尔图西玛) 结合博尔特佐米布,莱纳利多米德和德克萨米松作为新诊断的多发性骨髓瘤的成年人第一线治疗,而这些成年人不符合干细胞移植的条件. The FDA has approved Sanofi's Sarclisa (siltuximab) with bortezomib, lenalidomide, and dexamethasone as a first-line treatment for adults with newly diagnosed multiple myeloma not eligible for stem cell transplant. 这是Sarclisa在美国的第三次批准也是第一次批准新诊断的病人 This is Sarclisa's third approval in the US and its first for newly diagnosed patients. 根据IMROZ第3阶段的研究,这项批准表明,与标准治疗相比,疾病进展减少了40%。 The approval, based on the IMROZ phase 3 study, demonstrated a 40% reduction in disease progression compared to standard treatment.

September 23, 2024

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