StoryRegulatory
EU approves Enhertu with pertuzumab as first-line treatment for HER2-positive breast cancer
The European Union approved Enhertu combined with pertuzumab as a first-line treatment for adults with HER2-positive metastatic breast cancer, based on the Phase III DESTINY-Breast09 trial. The combination cut the risk of progression or death by 44% against the standard THP regimen.
- Hazard ratio 0.56 (95% CI 0.44 to 0.71) versus THP.
- Median progression-free survival 40.7 months versus 26.9 months.
- The trial enrolled 1,157 patients overall; 383 were in the hazard ratio analysis.