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FDA Approval

FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Gastric Cancer

February 05, 2021

On January 15, 2021, the Food and Drug Administration (FDA) granted approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma.

This approval was based on efficacy results from the multicenter, open-label, DESTINY-Gastric01 trial. This trial randomized patients with gastric or gastroesophageal adenocarcinoma in a 2:1 ratio to receive fam-trastuzumab deruxtecan-nxki or physician’s choice of irinotecan or paclitaxel monotherapy.

The main efficacy outcome measures were overall survival (OS) and objective response rate (ORR) determined by independent central review per RECIST 1.1. Secondary outcome measures were progression-free survival and duration of response (DOR).

In the fam-trastuzumab deruxtecan-nxki arm, OS was 12.5 months compared with 8.4 months in the irinotecan or paclitaxel arm (HR 0.59; 95% CI: .39, .88, P = .0097). The ORR was 40.5% vs 11.3%, respectively.

In addition, median PFS was 5.6 months in the fam-trastuzumab deruxtecan-nxki arm compared with 3.5 months in the irinotecan or paclitaxel arm. Median DOR was 11.3 months vs 3.9 months, respectively.

The most common adverse events occurring in ≥20% of patients, 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.—Janelle Bradley

Source: US Food and Drug Administration. FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas. January 15, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-her2-positive-gastric-adenocarcinomas. Accessed February 5, 2021.

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