Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
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
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
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
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