林业发展局接受了Nuvalent对ROS1呈阳性的肺癌的药物申请,预计2026年9月作出决定。 FDA accepted Nuvalent’s drug application for ROS1-positive lung cancer, with a decision expected in September 2026.

Nuvalent宣布林业发展局接受其NDA,用于在TKTI治疗过的ROS1阳性NSCL中使用Zidesamtinib,PDUFA日期为2026年9月18日,并计划美国今年晚些时候可能推出。 Nuvalent announced FDA acceptance of its NDA for zidesamtinib in TKI-pretreated ROS1-positive NSCLC, with a PDUFA date of September 18, 2026, and plans for a potential U.S. launch later this year. 预计2026年底将为TKI-naïve病人提交申请。 A submission for TKI-naïve patients is expected in late 2026. 对于ALK阳性NSCLC的NVL-655, 2026年初将NDA作为目标,辅以第3阶段数据,显示耐久反应和有力的CNS活动。 For NVL-655 in ALK-positive NSCLC, an NDA is targeted for early 2026, supported by phase 3 data showing durable responses and strong CNS activity. 该公司引用了快速招生,医生兴趣和差异化形象,安全数据显示可控的转氨酶升高. The company cited rapid enrollment, physician interest, and a differentiated profile, with safety data showing manageable transaminase elevations. Nuvalent还计划到年底披露一名新的开发候选人,并有14亿美元现金支持全球商业化。 Nuvalent also plans to disclose a new development candidate by year-end and has $1.4 billion in cash to support global commercialization.