FDA grants breakthrough therapy designation to Enhertu for gastric cancer subset

The FDA granted breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki for treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The designation applies to use of fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) by patients who received two or more prior regimens, including trastuzumab (Herceptin, Genentech).Fam-trastuzumab deruxtecan-nxki is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence asRead More

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