Nuvation Bio Announces The U.S. FDA Accepts For Priority Review Nuvation Bio's New Drug Application For Taletrectinib For The Treatment Of Advanced ROS1-Positive Non-Small Cell Lung Cancer
Nuvation Bio Announces The U.S. FDA Accepts For Priority Review Nuvation Bio's New Drug Application For Taletrectinib For The Treatment Of Advanced ROS1-Positive Non-Small Cell Lung Cancer
Nuvation Bio Inc. (NYSE:NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that the U.S. FDA has accepted the company's NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. Priority Review designation underscores the significant advancement taletrectinib may offer patients with ROS1+ NSCLC, for which there remains a high unmet need for new treatment options. Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs.New Drug Application (NDA) is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib that demonstrated durable responses and prolonged progression-free survival in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)
新药申请（NDA）基于taletrectinib的关键性第二阶段TRUSt-I和TRUSt-II研究的汇总数据，这些研究显示出持久的反应和延长的无进展生存期，适用于晚期ROS1阳性（ROS1+）非小细胞肺癌（NSCLC）患者。
If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC
如果获得批准，taletrectinib将代表晚期ROS1+ NSCLC患者的一种潜在优质治疗选择。
U.S. Food and Drug Administration (FDA) has assigned a target action date of June 23, 2025
美国食品和药物管理局（FDA）已将目标行动日期定为2025年6月23日。
Nuvation Bio Inc. (NYSE:NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced that the U.S. FDA has accepted the company's NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI), for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. Priority Review designation underscores the significant advancement taletrectinib may offer patients with ROS1+ NSCLC, for which there remains a high unmet need for new treatment options. Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs.
Nuvation Bio Inc.（纽交所：NUVB）是一家全球生物制药公司，致力于解决肿瘤学中一些最迫切的未满足需求，今天宣布美国FDA已接受该公司对taletrectinib的NDA申请，该药物为一种研究性新一代ROS1酪氨酸激酶抑制剂（TKI），用于治疗晚期ROS1+ NSCLC（不限于具体类型）。美国FDA已给予该申请优先审评，并将处方药用户费用法（PDUFA）目标日期定为2025年6月23日。优先审评的指定强调了taletrectinib可能为ROS1+ NSCLC患者提供的显著进展，因此该疾病对新的治疗选择仍存在迫切需求。taletrectinib此前已获得孤儿药资格，是目前在研的唯一已获得美国FDA突破性治疗指定的ROS1 TKI，用于治疗局部晚期或转移性ROS1+ NSCLC患者，无论他们是否之前接受过ROS1 TKI治疗。
