FDA approves Enhertu for HER2-positive gastric adenocarcinomas

On January 15, the Food and Drug Administration approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally-advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

In December 2019, Enhertu, which was developed by Japan’s Daiichi Sankyo (TYO: 4568) and UK pharma major AstraZeneca (LSE: AZN), gained FDA clearance for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Efficacy was evaluated in a multicenter, open-label, randomized trial (DESTINY-Gastric01, NCT03329690) in 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. A total of 188 patients were randomized (2:1) to receive fam-trastuzumab deruxtecan-nxki 6.4 mg/kg intravenously every 3 weeks or physician’s choice of either irinotecan or paclitaxel monotherapy.