AstraZeneca and Daiichi Sankyo Win FDA Nod for Enhertu Treating HER2-Positive Gastric Cancer

AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the FDA for treating adult patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The agency approved the antibody drug conjugate for treating adults with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen.

The approval was based on positive results from a phase 2 trial in Japan and South Korea that showed Enhertu led to improvement in overall survival and response rate vs. chemotherapy.