Biopharmaceutical company AstraZeneca plc (LSE/STO/NYSE: AZN) and its Japanese pharmaceutical partner Daiichi Sankyo (TYO: 4568) said on Tuesday that the European Commission has approved Enhertu (trastuzumab deruxtecan) as a monotherapy for the adjuvant treatment of adults with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment.
The approval, based on results from the Phase III DESTINY-Breast05 trial, marks the first EU approval of Enhertu in an early breast cancer setting with curative intent.
In the trial, Enhertu was found to reduce the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1), with a hazard ratio of 0.47 (95% confidence interval 0.34-0.66; p
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