The US Food and Drug Administration has approved datopotamab deruxtecan-dlnk for treating adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Datopotamab deruxtecan-dlnk is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. Clinical evidence The safety and efficacy of this therapy were evaluated in a clinical trial involving 732 patients, compared to chemotherapy such as eribulin, capecitabine, vinorelbine, or gemcitabine.
In the study, the datopotamab deruxtecan-dlnk achieved a significantly longer progression-free survival of 6.9 months compared to 4.9 months in the chemotherapy group. However, median overall survival was similar between the…
