美国食品和药物管理局批准了Zovegalisib-fulvestrant组合治疗晚期乳腺癌的突破性治疗, FDA grants breakthrough status to zovegalisib-fulvestrant combo for advanced breast cancer, boosting stock.

根据早期试验数据显示安全性和初步抗瘤活性,FDA授予佐维加利西布与富尔韦斯特兰特联合治疗PIK3CA突变,激素受体阳性,HER2阴性晚期乳腺癌的成年人突破性治疗指标. The FDA granted Breakthrough Therapy Designation to zovegalisib combined with fulvestrant for treating adults with PIK3CA-mutant, hormone receptor-positive, HER2-negative advanced breast cancer, based on early trial data showing safety and preliminary antitumor activity. 指定旨在加速开发和审查,提供加强的FDA支持. The designation aims to accelerate development and review, offering enhanced FDA support. Relay Therapeutics股价在公告后盘前交易上涨超过3%，延续强劲上涨趋势，较去年涨幅达93%。 Relay Therapeutics' stock rose over 3% in pre-market trading following the announcement, continuing a strong upward trend with a 93% increase over the past year.