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# Daiichi Sankyo’s Enhertu for Gastric Cancer
- URL: https://www.fdaweb.com/daiichi-sankyos-enhertu-for-gastric-cancer/
- Published: 2021-01-19T12:00:00.000Z
- Updated: 2026-09-14T16:43:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148477

FDA has approved a Daiichi Sankyo BLA for 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. Approval was based on data from the DESTINY-Gastric01 (NCT03329690) trial 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, an FDA release says. (XXINSERT LINKXX)

In the study, 188 patients were randomized (2:1) to receive fam-trastuzumab deruxtecan-nxki intravenously every three weeks or physician’s choice of either irinotecan or paclitaxel monotherapy. Overall survival was 12.5 months in the fam-trastuzumab deruxtecan-nxki arm compared with 8.4 months in the irinotecan or paclitaxel arm. The objective response rate was 40.5% in the fam-trastuzumab deruxtecan-nxki arm compared with 11.3% (or those receiving irinotecan or paclitaxel.

The most common adverse reactions including laboratory abnormalities were anemia, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, nausea, decreased appetite, increased aspartate aminotransferase, fatigue, increased blood alkaline phosphatase, increased alanine aminotransferase, diarrhea, hypokalemia, vomiting, constipation, increased blood bilirubin, pyrexia, and alopecia, FDA says. “The Prescribing Information includes a Boxed Warning to advise health professionals of the risks of interstitial lung disease and embryo-fetal toxicity.” it adds.