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)
新藥申請（NDA）基於taletrectinib的關鍵性第二階段Trust-I和Trust-II研究的彙總數據，這些研究顯示出持久的反應和延長的無進展生存期，適用於晚期ROS1陽性（ROS1+）非小細胞肺癌（NSCLC）患者。
If approved, taletrectinib represents a potential best-in-class treatment option for patients with advanced ROS1+ NSCLC
如果獲得批准，taletrectinib將代表晚期ROS1+ NSCLC患者的一種潛在優質治療選擇。
U.S. Food and Drug Administration (FDA) has assigned a target action date of June 23, 2025
美國食品和藥物管理局（FDA）已將目標行動日期定爲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.（紐交所：NUVB）是一家全球生物製藥公司，致力於解決腫瘤學中一些最迫切的未滿足需求，今天宣佈美國FDA已接受該公司對taletrectinib的NDA申請，該藥物爲一種研究性新一代ROS1酪氨酸激酶抑制劑（TKI），用於治療晚期ROS1+ NSCLC（不限於具體類型）。美國FDA已給予該申請優先審評，並將處方藥用戶費用法（PDUFA）目標日期定爲2025年6月23日。優先審評的指定強調了taletrectinib可能爲ROS1+ NSCLC患者提供的顯著進展，因此該疾病對新的治療選擇仍存在迫切需求。taletrectinib此前已獲得孤兒藥資格，是目前在研的唯一已獲得美國FDA突破性治療指定的ROS1 TKI，用於治療局部晚期或轉移性ROS1+ NSCLC患者，無論他們是否之前接受過ROS1 TKI治療。
譯文內容由第三人軟體翻譯。
