Posted by Michael Wonder on 16 Jan 2021
FDA approves fam-trastuzumab deruxtecan-nxki for HER2 positive gastric adenocarcinomas
15 January 2021 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2 positive gastric or gastro-esophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
Efficacy was evaluated in a multicenter, open-label, randomised trial (DESTINY-Gastric01) in patients with HER2-positive locally advanced or metastatic gastric or gastro-oesophageal adenocarcinoma who had progressed on at least two prior regimens, including trastuzumab, a fluoropyrimidine- and a platinum-containing chemotherapy.
