Enhertu receives priority review in the US for HER2-Low and HER2-Ultralow metastatic breast cancer patients previously treated with endocrine therapy

CAR-T Digest - August 2020

Weekly Digest - October 2024

1 Oct 2024: Enhertu receives priority review in the US for HER2-Low and HER2-Ultralow metastatic breast cancer patients previously treated with endocrine therapy

Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the FDA for treating unresectable or metastatic HER2-low and HER2-ultralow breast cancer
The application is based on DESTINY-Breast06 Phase III trial results, showing Enhertu reduced disease progression or death by 37% compared to chemotherapy
Enhertu showed a median progression-free survival of 13.2 months versus 8.1 months for chemotherapy
FDA’s final decision is expected in Q1 2025
Enhertu is already approved in over 65 countries for HER2-low metastatic breast cancer following previous treatments