FDA授予抗癌小分子优先审评资格，有望今年上市
Celcuity今日宣布，美国FDA已接受其在研广谱 PI3K/AKT/mTOR（PAM） 抑制剂gedatolisib的新药申请（NDA），用于治疗激素受体阳性（HR+）、HER2阴性（HER2-）的 PIK3CA 野生型晚期乳腺癌（ABC）患者。 FDA授予该申请优先审评资格，并预计于2026年7月17日前完成审评。 Gedatolisib是一款多靶点抑制剂，可强效靶向全部四种I类PI3K蛋白 同工酶 （isoforms）以及mTORC1和mTORC2，从而实现对PAM通路的全面阻断。Gedatolisib此前已基于积极的早期临床数据获得突破性疗法认定和快速通道资格。
礼来抗癌ADC获FDA授予突破性疗法认定
礼来（Eli Lilly and Company）今日宣布，美国FDA已授予其在研抗体偶联药物（ADC）sofetabart mipitecan（LY4170156）突破性疗法认定，用于治疗既往接受过贝伐珠单抗和ADC疗法mirvetuximab soravtansine（如适用）的铂耐药性上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。 Sofetabart mipitecan是一款新型叶酸受体α（FRα）靶向的ADC，采用专有连接子技术，并以exatecan作为有效载荷。
[1] Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. Retrieved January 20, 2026 from https://www.globenewswire.com/news-release/2026/01/20/3221601/0/en/Celcuity-Announces-FDA-Acceptance-of-New-Drug-Application-for-Gedatolisib-in-HR-HER2-PIK3CA-Wild-Type-Advanced-Breast-Cancer.html
[2] Lilly's sofetabart mipitecan receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer. Retrieved January 20, 2026 from https://www.prnewswire.com/news-releases/lillys-sofetabart-mipitecan-receives-us-fdas-breakthrough-therapy-designation-for-the-treatment-of-certain-patients-with-platinum-resistant-ovarian-cancer-302665319.html
[3] Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting. Retrieved January 20, 2026 from https://investor.lilly.com/news-releases/news-release-details/lilly-presents-first-clinical-data-its-investigational-next
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