Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events
Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting
Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo
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
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