Cogent Biosciences宣布FDA接受其新药申请,针对贝祖克拉替尼联合舒尼替尼治疗胃肠道间质瘤患者获得优先审评资格

美股速递
May 28

Cogent Biosciences, Inc.(COGT)宣布,美国食品药品监督管理局(FDA)已接受其新药申请(NDA),并对贝祖克拉替尼(bezuclastinib)联合舒尼替尼(sunitinib)用于治疗胃肠道间质瘤(GIST)患者的方案授予优先审评资格。

这一决定标志着该药物组合在监管审批进程中迈出了关键一步。优先审评资格的授予通常意味着FDA认为该疗法有潜力在治疗严重疾病方面提供显著优势。对于患有GIST的患者群体而言,这可能是一个重要的治疗新选择。

公司表示,将全力配合FDA的审评流程,以期尽快将这一潜在疗法带给有需要的患者。

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