美国食品药物监督管理局对生物制品许可申请的受理令我们备受鼓舞，因为我们致力于使 datopotamab deruxtecan 成为首个获批用于治疗既往接受过全身治疗但病情恶化的非鳞状非小细胞肺癌患者的靶向TROP2抗体偶联药物。我们期待与FDA密切合作，将 datopotamab deruxtecan 带给患者。"TROPION-Lung01 的研究结果已在2023年欧...
美国食品药物监督管理局对生物制品许可申请的受理令我们备受鼓舞,因为我们致力于使 datopotamab deruxtecan 成为首个获批用于治疗既往接受过全身治疗但病情恶化的非鳞状非小细胞肺癌患者的靶向TROP2抗体偶联药物。我们期待与FDA密切合作,将 datopotamab deruxtecan 带给患者。" TROPION-Lung01 的研究结果已在2023年欧...
美国食品药物监督管理局对生物制品许可申请的受理令我们备受鼓舞,因为我们致力于使 datopotamab deruxtecan 成为首个获批用于治疗既往接受过全身治疗但病情恶化的非鳞状非小细胞肺癌患者的靶向TROP2抗体偶联药物。我们期待与FDA密切合作,将 datopotamab deruxtecan 带给患者。" TROPION-Lung01 的研究结果已在2023年欧...
美国食品药物监督管理局对生物制品许可申请的受理令我们备受鼓舞,因为我们致力于使 datopotamab deruxtecan 成为首个获批用于治疗既往接受过全身治疗但病情恶化的非鳞状非小细胞肺癌患者的靶向TROP2抗体偶联药物。我们期待与FDA密切合作,将 datopotamab deruxtecan 带给患者。" TROPION-Lung01 的研究结果已在2023年欧...
FDA Accepts Datopotamab Deruxtecan BLA for Patients With Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
AstraZeneca and Daiichi Sankyo have moved swiftly to file for FDA approval of a second indication for their TROP2-directed antibody-drug conjugate datopotamab deruxtecan ( News AZ, Daiichi eye December verdict for TROP2 ADC The FDA has started a review of AstraZeneca and Daiichi Sankyo’...
Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and duration...
Daiichi Sankyo and AstraZeneca’s Biologics License Application for datopotamab deruxtecan has been accepted in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell l...
近日,第一三共/阿斯利康联合开发和推广的TROP2 ADC德达博妥单抗(datopotamab deruxtecan,Dato-DXd)的新药上市许可申请正式获药监局受理,用于治疗既往在不可切除或转移性疾病阶段接受过系统治疗的HR阳性、HER2阴性(IHC 0、IHC 1+或IHC 2+/ISH-)的不可切除或转移性乳腺癌成人患者。
accepted application for advanced nonsquamous non-small cell lung cancer in the US, along with additional regulatory reviews underway in China, the EU, Japan and other regions, we are working swiftly to brin...