FDA accepts Enhertu (trastuzumab deruxtecan) supplemental biologics licence application (sBLA) and priority review for HER2-positive metastatic gastric cancer

The sBLa was based on results from the DESTINY-Gastric01, which demonstrated a statistically significant improvement in objective response rate and overall survival. A regulatory decision for this indication has been set for the first quarter of 2021.

PharmaTimes