FDA approves Enhertu as the first treatment for HER2-low breast cancer

Daiichi Sankyo/Enhertu

The FDA approved Enhertu for metastatic breast cancer with low HER2 levels, a group that had been treated as HER2-negative and had no targeted option. The DESTINY-Breast04 trial showed that the conjugate roughly doubled time to progression and added more than six months of survival versus chemotherapy. It created a new HER2-low treatment category.

• 557 patients randomised 2:1 to Enhertu or physician's choice of chemotherapy.
• Progression-free survival 9.9 vs 5.1 months (HR 0.50).
• Overall survival 23.4 vs 16.8 months (HR 0.64).