[2] Datopotamab deruxtecan is indicated for the treatment of adults with unresectable or metastatic, hormone receptor positive, human epidermal growth factor receptor 2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

[4] Other side effects include pneumonitis, infusion-related reactions, oral mucositis, and ocular surface events.

[2] A total of 732 patients were randomized (1:1) to datopotamab deruxtecan-dlnk (n=365) or investigator's choice of chemotherapy (n=367); eribulin (60%), capecitabine (21%), vinorelbine (10%), or gemcitabine (9%).

[2][5] In December 2024, the US Food and Drug Administration granted the application for datopotamab deruxtecan breakthrough therapy designation.

[6] In January 2025, the EU CHMP adopted a positive opinion for datopotamab deruxtecan for, the treatment of breast cancer.