AstraZeneca and Daiichi Sankyo announced that Enhertu(trastuzumab deruxtecan) has received marketing authorization from the European Commission as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease following neoadjuvant taxane-based and HER2-targeted therapy.
The regulatory milestone marks the first approval for Enhertu in the curative-intent early breast cancer setting within the European Union. The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is supported by data from the global Phase III DESTINY-Breast05 clinical trial, which enrolled 1,635 patients and was published in The New England Journal of Medicine.
In the trial, Enhertu (5.4 mg/kg) demonstrated a statistically significant 53% reduction in the risk of invasive disease recurrence or death compared to the standard-of-care trastuzumab emtansine (T-DM1) (hazard ratio [HR] = 0.47; 95% CI: 0.34–0.66; p < 0.0001). At three years, the invasive disease-free survival (IDFS) rate reached 92.4% for patients receiving Enhertu versus 83.7% for those treated with T-DM1. The safety profile observed in the study was consistent with previous trials, with no new safety concerns identified.
”For patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy, reducing the risk of disease recurrence is critical for sustained long-term outcomes,” said Dr. Sibylle Loibl, lead investigator of the DESTINY-Breast05 trial. “Demonstrating a more than 50% risk reduction over the standard of care gives this therapy the potential to transform clinical management in this curative-intent setting.”
Following this approval, a $75 million milestone payment is due from AstraZeneca to Daiichi Sankyo. Enhertu is now approved in more than 35 countries for this specific adjuvant indication.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
