AstraZeneca and Daiichi Sankyo’s Enhertu (Trastuzumab deruxtecan) has received FDA approval for treating HR+, HER2-low or HER2-ultralow metastatic breast cancer in patients who have progressed after one or more endocrine therapies

The approval, granted after Priority Review and BTD, is based on the DESTINY-Breast06 Phase 3 trial results, presented at ASCO 2024

Enhertu demonstrated a 36% reduction in disease progression or death risk compared to chemotherapy (HR 0.64), with a mPFS survival of 13.2 months and ORR was 62.6%

The approval expands Enhertu’s use to a broader population and following the approval, AstraZeneca will pay Daiichi Sankyo a $175 million milestone for this indication