FDAは1歳以上でNPM1変異のAML治療にRevuforjを承認した. 
FDA approves Revuforj for NPM1-mutated AML in patients aged one and older.
FDAは,NPM1変異を宿す再発または耐性急性骨髄性白血病 (AML) の成人および1歳以上の子供向けにRevuforj (revumenib) を承認し,KMT2A再編成白血病に対する以前の承認を拡大しました. The FDA has approved Revuforj (revumenib) for adults and children aged one year and older with relapsed or refractory acute myeloid leukemia (AML) harboring an NPM1 mutation, expanding its prior approval for KMT2A-rearranged leukemia. AUGMENT-101号の検診結果に基づくこの判決は,241人の患者を対象とする検診結果に基づいて,全額の反応又は部分的体質回復率を23.1%表示し,平成4ヶ月の反応期間を平均的に表明した. The decision, based on data from the AUGMENT-101 trial involving 241 patients, showed a 23.1% complete response or partial hematologic recovery rate, with a median response duration of 4.5 months. この薬は,異変症,QTc拡張,胚髄毒性等の危険を伴う. The drug carries risks including differentiation syndrome, QTc prolongation, and embryo-fetal toxicity. Syndax製薬もSyndAccesss,金融・患者支援の提供に関する支援プログラムを発足した. Syndax Pharmaceuticals also launched SyndAccess®, a support program offering financial and patient assistance.
