FDA clears Enhertu for first‑line HER2+ disease — Roche tests expanded to match

The FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a first‑line treatment for unresectable or metastatic HER2‑positive breast cancer. The agency’s decision expands Enhertu’s label into the first‑line metastatic setting. Concurrently, Roche won expanded FDA clearances for its Pathway anti‑HER2 antibody and Ventana HER2 Dual ISH assays to identify patients eligible for Enhertu across the full spectrum of HER2 expression. Roche said the approvals allow Pathway and Ventana tests to be used together for more precise patient selection. The dual approvals change clinical pathways for HER2 testing and treatment selection, enabling oncologists to pair diagnostics and the newly approved combination therapy for earlier lines of metastatic care.