The FDA has approved datopotamab deruxtecan (Datroway; Dato-DXd) as a first-line option for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on results from the phase 3 TROPION-Breast02 trial, including improved overall survival versus investigator’s-choice chemotherapy (HR 0.79). In parallel for the broader breast cancer landscape, AstraZeneca’s breast cancer drug received a positive opinion from EU regulators, following an FDA advisory committee vote against the drug. The split underscores how dossier specifics and review pathways can produce different outcomes across regions, even for the same therapy. For endometrial cancer, updated data from the phase 3 RUBY trial showed long-term progression-free survival durability with dostarlimab plus carboplatin/paclitaxel in dMMR/MSI-H primary advanced or recurrent disease. Mixture cure modeling suggested a sizable fraction of patients may have potential for cure, with additional readouts expected at ASCO 2026.