林业发展局接受了Celcuity的药物申请,治疗患有PIK3CA野型肿瘤的病人的乳癌,预计2026年7月17日会作出决定。 FDA accepted Celcuity’s drug application for treating advanced breast cancer in patients with PIK3CA wild-type tumors, with a decision expected by July 17, 2026.

美国食品和药物管理局已批准Celcuity的NDA用于治疗PIK3CA野生型瘤患者的HR+/ HER2-高级乳腺癌. The FDA has accepted Celcuity’s NDA for gedatolisib, a multi-targeted PI3K/AKT/mTOR inhibitor, for treating HR+/HER2- advanced breast cancer in patients with PIK3CA wild-type tumors. 根据第3期VICTORIA-1试验数据,该申请在优先审查中,PDUFA目标日期为2026年7月17日,该试验数据显示,用格达托利西布与富尔韦斯特兰特联合,或不使用帕尔博西基利布,无进展生存率显著改善. The application, under Priority Review with a PDUFA goal date of July 17, 2026, is based on Phase 3 VIKTORIA-1 trial data showing significant improvement in progression-free survival with gedatolisib combined with fulvestrant, with or without palbociclib. 该药物正在额外的第3阶段试验和其他固态肿瘤中进行评估。 The drug is being evaluated in additional Phase 3 trials and other solid tumors.