FDA grants priority review to Enhertu for gastric cancer subset

The FDA granted priority review to fam-trastuzumab deruxtecan-nxki for treatment of HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma.Fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 inhibitor payload; and a tetrapeptide-based cleavable linker.The agent is approved in the United States for treatment of adults with unresectable orRead More

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