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The FDA said recently that it has expanded the range of adaptations to AstraZeneta (fam-trastuzumab deruxtecan-nxki) to include locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma, which has previously been treated with tricoporosis.
FDA approved the antibody-drug association Enhertu at the end of 2019, allowing it to treat HER2-positive breast cancer that had previously been treated with at least two antiHER2 drugs.
's latest approval is supported by data from phase II DESTINY-Gastric01 trial, which involved 126 her2-positive patients with localized advanced or metastatic gastric or gastroesophageal adenocarcinoma who had underwent at least two previous treatments, including tricroutin, fluorine, and platinum-containing chemotherapy.
detailed study, published last year at the annual meeting of the American Society of Clinical Oncology (ASCO), showed that objective remission rates (ORRs) were significantly higher in patients treated with Enhertu than in patients receiving chemotherapy of the researchers' choice (42.9% vs. 12.5%).
of patients in the Enhertu group had a total survival of 12.5 months, compared with 8.4 months in the control group.
5.6 months in patients in the Enhertu group, compared with 3.5 months in the control group.