Enhertu first-line approval: FDA clears combo for HER2 metastatic patients

The FDA granted a label expansion for Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan), clearing the antibody-drug conjugate for use in combination with pertuzumab as a first-line regimen in unresectable or metastatic HER2‑positive breast cancer. The decision follows pivotal data presented at ASCO and positions Enhertu to supplant long‑standing HER2 regimens. Roche simultaneously secured expanded approvals for companion HER2 diagnostics to identify patients across the HER2 expression spectrum who may be eligible for Enhertu-based therapy, enabling broader patient selection in clinical practice.