AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The recommendation is based on results from the DESTINY-Breast09 Phase III trial, which demonstrated a 44% reduction in the risk of disease progression or death compared with the current standard-of-care regimen, with median progression-free survival exceeding three years. If approved by the European Commission, the combination would become the first new first-line treatment option in the European Union for HER2-positive metastatic breast cancer in more than a decade.