FDA widens Enhertu use — diagnostics cleared to match the label

The FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for first‑line HER2‑positive metastatic breast cancer and cleared expanded claims for Roche’s Pathway and Ventana HER2 assays to identify eligible patients across the HER2 expression spectrum. Regulators and companies described the moves as aligning diagnostic labeling with the therapy’s broadened clinical utility.