AstraZeneca and Daiichi Sankyo Receive FDA Approval for Enhertu in HER2-Positive Gastric Cancer

AstraZeneca and Daiichi Sankyo today announced that the FDA has approved Enhertu (trastuzumab deruxtecan) for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In the Phase 3 DESTINY-Gastric02 trial, Enhertu demonstrated an overall response rate of 41.8% in patients with HER2-positive gastric cancer. The median duration of response was 8.1 months. This approval expands the use of Enhertu into gastric cancer, adding to its growing list of approved indications across multiple HER2-expressing tumor types.