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Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data Submission to be reviewed under FDA Real Time Oncology Review and Project Orbis If approved,...
AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have ...
Daiichi Sankyo and AstraZeneca’s ENHERTU showed a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population Results reaffirm...
AstraZeneca and Daiichi Sankyo’s ENHERTU showed objective response rates of 49% and 56% with 5.4mg/kg and 6.4mg/kg doses respectively in primary analysis ENHERTU provided a median...
Designations for Daiichi Sankyo and AstraZeneca's ENHERTU include patients with HER2 expressing metastatic solid tumors and HER2 positive metastatic colorectal cancer ENHERTU has now been granted...