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6-K: Dato-DXd NSQ NSCLC Application Withdrawn in EU

6-K: Dato-DXd NSQ NSCLC Application Withdrawn in EU

6-K:Dato-DXd NSQ NSCLC 在歐盟的申請被撤回
美股SEC公告 ·  2024/12/26 16:07

牛牛AI助理已提取核心訊息

AstraZeneca and Daiichi Sankyo have voluntarily withdrawn their EU marketing authorization application for datopotamab deruxtecan (Dato-DXd) in treating advanced nonsquamous non-small cell lung cancer (NSCLC). The withdrawal decision followed feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use.The companies remain committed to developing Dato-DXd for lung cancer patients through their clinical program, which includes seven pivotal trials in various lung cancer settings. Their separate EU application for Dato-DXd in hormone receptor-positive, HER2-negative metastatic breast cancer continues under review.Dato-DXd, a TROP2-directed antibody drug conjugate, has received Breakthrough Therapy Designation from the FDA for EGFR-mutated NSCLC treatment. The drug is currently being evaluated in over 20 clinical trials across multiple cancers, including NSCLC and breast cancer indications.
AstraZeneca and Daiichi Sankyo have voluntarily withdrawn their EU marketing authorization application for datopotamab deruxtecan (Dato-DXd) in treating advanced nonsquamous non-small cell lung cancer (NSCLC). The withdrawal decision followed feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use.The companies remain committed to developing Dato-DXd for lung cancer patients through their clinical program, which includes seven pivotal trials in various lung cancer settings. Their separate EU application for Dato-DXd in hormone receptor-positive, HER2-negative metastatic breast cancer continues under review.Dato-DXd, a TROP2-directed antibody drug conjugate, has received Breakthrough Therapy Designation from the FDA for EGFR-mutated NSCLC treatment. The drug is currently being evaluated in over 20 clinical trials across multiple cancers, including NSCLC and breast cancer indications.
阿斯利康和第一三共自願撤回其在歐盟申請的達託替康(Dato-DXd)營銷授權,以治療晚期非鱗狀非小細胞肺癌(NSCLC)。撤回決定是基於歐洲藥品管理局人用醫藥產品委員會的反饋。這兩家公司仍然致力於通過其臨牀項目開發Dato-DXd,以幫助肺癌患者,該項目包括在各種肺癌背景下的七項關鍵試驗。它們針對Dato-DXd在激素受體陽性、HER2陰性轉移性乳腺癌的獨立歐盟申請仍在審查中。Dato-DXd是一種針對TROP2的抗體藥物偶聯物,已獲得FDA對EGFR突變型NSCLC治療的突破性治療認定。該藥物目前正在針對多種癌症進行20多項臨牀試驗,包括NSCLC和乳腺癌適應症。
阿斯利康和第一三共自願撤回其在歐盟申請的達託替康(Dato-DXd)營銷授權,以治療晚期非鱗狀非小細胞肺癌(NSCLC)。撤回決定是基於歐洲藥品管理局人用醫藥產品委員會的反饋。這兩家公司仍然致力於通過其臨牀項目開發Dato-DXd,以幫助肺癌患者,該項目包括在各種肺癌背景下的七項關鍵試驗。它們針對Dato-DXd在激素受體陽性、HER2陰性轉移性乳腺癌的獨立歐盟申請仍在審查中。Dato-DXd是一種針對TROP2的抗體藥物偶聯物,已獲得FDA對EGFR突變型NSCLC治療的突破性治療認定。該藥物目前正在針對多種癌症進行20多項臨牀試驗,包括NSCLC和乳腺癌適應症。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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