On 3 January 2025, the U.S. Food and Drug Administration approved Datopotamab deruxtecan, now branded as Datroway, for the treatment of adults with previously treated, unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer. The therapy had been granted Breakthrough Therapy Designation in late 2024, and its approval signals a major step forward for patients who have exhausted existing treatment options. Datroway is an antibody-drug conjugate designed to target Trop-2, a protein commonly found on breast cancer cells, and deliver a cytotoxic payload directly to tumors. This targeted approach aims to maximize efficacy while limiting damage to healthy tissues.

The decision is viewed as a significant moment for both patients and the oncology field. For patients, it offers a much-needed new option in an area with limited choices once standard therapies fail. For researchers and the broader pharmaceutical industry, it reflects the growing promise of antibody-drug conjugates as a class of medicines that are rapidly reshaping cancer treatment strategies. Soon after the U.S. decision, the European Medicines Agency also issued a positive opinion recommending approval, suggesting that access could expand internationally later this year. As real-world data begins to emerge in 2025, attention will turn to how Datroway performs outside of clinical trials and how it fits into evolving treatment guidelines for breast cancer.