Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care
DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights
Application based on results from the TROPION-Breast01 Phase III trial
The validations confirm the completion of the applications and commence the scientific review process
Submission to be reviewed under FDA real-time oncology review and Project Orbis
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
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