FDA approves expansion of indication for Enhertu in metastatic HER2-positive gastric or gastroesophageal adenocarcinoma.- AstraZeneca/Daiichi Sankyo

AstraZeneca and Daiichi Sankyo have announced that the FDA has approved label expansion for Enhertu (fam-trastuzumab deruxtecan-nxki) to include adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma that would have previously been treated with a trastuzumab-based regimen. The therapy was granted an accelerated approval in 2019 to treat unresectable HER2-positive breast cancer in patients who have received at least two prior anti-HER2-based regimens in the metastatic setting. This application, which was assessed under a priority review, was supported by data from the Phase II DESTINY-Gastric01 trial involving 126 patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma who had progressed on at least two prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy.