The European Commission has approved Enhertu for adults with HER2-positive early breast cancer who have residual invasive disease after treatment before surgery, marking the drug’s first European Union approval in early breast cancer.
The authorization covers treatment after surgery for patients previously given taxane-based chemotherapy and HER2-targeted therapy. Enhertu, or trastuzumab deruxtecan, is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
Approval was based on the Phase 3 DESTINY-Breast05 trial, which enrolled 1,635 patients with residual invasive disease and a high risk of recurrence. The randomized, open-label study compared Enhertu with trastuzumab emtansine, known as T-DM1.
Enhertu reduced the risk of invasive disease recurrence or death by 53%, with a hazard ratio of 0.47 and a p-value below 0.0001. At three years, 92.4% of Enhertu recipients were alive without invasive disease, compared with 83.7% receiving T-DM1.
The drug also reduced the risk of disease recurrence or death by 53% under the trial’s broader disease-free survival measure. Three-year rates were 92.3% and 83.5%, respectively.
Safety findings in DESTINY-Breast05 were consistent with Enhertu’s established profile, with no new concerns identified. A separate pooled safety analysis across tumor types reported severe blood disorders, fatigue and nausea among adverse reactions. Fatal interstitial lung disease or pneumonitis occurred in 0.8% of patients in that analysis.
The approval triggers a $75 million milestone payment from AstraZeneca to Daiichi Sankyo, which records Enhertu sales in most EU territories.
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