FDAはASC4FIRST試験の結果に基づいて,SCEMBLIXを第一線CML治療に承認した. FDA approves Scemblix for first-line CML treatment, based on ASC4FIRST trial results.

FDAは,新診断のフィラデルフィア染色体陽性慢性骨髄性白血病 (CML) の成人の第一線治療として,Scemblix (アシミニブ) を承認しました. 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. この決定は,標準のチロシンキナーゼ阻害剤の49%と比較して,Scemblixの48週後の68%の主要な分子応答率を示したASC4FIRST試験に基づいています. 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. 承認により治療選択肢が拡大し,CMLの臨床アプローチが変わることがあります. The approval expands treatment options and may alter the clinical approach to CML.