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阿斯利康TROP2 ADC药物临床数据未达预期 但支持上市申请

AstraZeneca TROP2 ADC drug clinical data falls short of expectations but supports marketing application

Breakings ·  May 29 20:51
In clinical trials, the TROP2 ADC drug DS-1062 (datopotamab deruxtecan), developed by AstraZeneca in collaboration with Daiichi Sankyo, the overall survival (OS) data did not meet statistical assumptions, but it was numerically beneficial to the drug. Although the primary OS endpoint was not reached, the Tropion-LUNG01 clinical study reached the primary study endpoint in progression-free survival (PFS), supporting the marketing application. Currently, the drug's marketing application is being reviewed by global regulators such as the US and the European Union. Industry insiders believe that although OS is the “gold standard” for drug review, the positive results of PFS may have a positive impact on the review. (every time)

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