StoryRegulatory
Enhertu plus pertuzumab approved in the US as first-line treatment for HER2-positive metastatic breast cancer
The FDA approved Enhertu with pertuzumab as the first treatment for HER2-positive metastatic breast cancer, the first new first-line option in more than a decade. In DESTINY-Breast09 the combination kept cancer from growing for a median 40.7 months versus 26.9 months on the long-standing standard of taxane chemotherapy, trastuzumab and pertuzumab.
- 1,157 patients; progression-free survival HR 0.56 (44% lower risk of progression or death).
- Complete responses 15% vs 8%.
- Lung inflammation in 12% of patients on the combination, fatal in 0.5%.
- Triggers a $150M milestone from AstraZeneca to Daiichi Sankyo.