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, where the antibody-drug conjugate improved overall survival and progression-free survival versus investigator’s-choice chemotherapy. Separately, the FDA cleared Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Tepmetko (tepotinib) to identify MET exon 14 skipping alterations in metastatic NSCLC, expanding coverage beyond tissue to include liquid biopsy. Foundation said the decision leverages its real-world data-powered approach using the Flatiron Health-Foundation Medicine clinico-genomic database. Taken together, the approvals underscore the FDA’s continued push toward pairing targeted oncology therapies with narrower biomarker selection—tightening treatment eligibility while expanding real-world feasibility via different sample types.