根据ASC4FIRST试验结果,FDA批准Scemblix作为一线CML治疗. FDA approves Scemblix for first-line CML treatment, based on ASC4FIRST trial results.

美国食品和药物管理局批准Scemblix (阿斯基米尼布) 作为新诊断的费城染色体阳性慢性髓性白血病 (CML) 的成年人治疗的第一线治疗. The FDA has approved Scemblix (asciminib) as a first-line treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. 这一决定是基于ASC4FIRST试验,该试验显示Scemblix在48周后的主要分子反应率为68%,而标准类型的激素激酶抑制剂则为49%. This decision is based on the ASC4FIRST trial, showing a major molecular response rate of 68% at 48 weeks for Scemblix, compared to 49% for standard tyrosine kinase inhibitors. 批准扩大了治疗选择的范围,并可能改变对CML的临床方法。 The approval expands treatment options and may alter the clinical approach to CML.

October 29, 2024

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