A European Medicines Agency panel recommended the approval of Enhertu, a cancer drug from AstraZeneca and Daiichi Sankyo. The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) targets patients with early-stage HER2-positive breast cancer who have residual invasive disease after pre-surgery treatment.
The recommendation is based on the Phase III DESTINY-Breast05 trial. Results showed Enhertu reduced the risk of disease recurrence or death by 53% compared to the current standard of care, trastuzumab emtansine (T-DM1).
The European Commission will now review the CHMP's opinion. A final marketing authorization decision for the European Union is pending.