AstraZeneca announces that the supplemental Biologics License Application (sBLA) for Enhertu has been accepted with priority review by the FDA to treat HER2-low or HER2-ultralow unresectable or metastatic breast cancer.
Based on the positive results of the DESTINY-Breast06 trial, this review could enable Enhertu to be marketed as early as 2025.
Enhertu demonstrated a 37% reduction in the risk of disease progression compared to chemotherapy.
The FDA has also granted Enhertu Breakthrough Therapy designation, underlining its potential for wider and earlier use.
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