FDA Grants First-Line Approval for Enhertu Combination in HER2-Positive Breast Cancer

The U.S. Food and Drug Administration has approved AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan) in combination with Roche’s Perjeta as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer confirmed by an FDA-approved test.

This new indication is supported by positive results from the Phase III DESTINY-Breast09 trial, which showed the Enhertu-Perjeta regimen significantly improved median progression-free survival (40.7 vs. 26.9 months) and reduced the risk of disease progression or death compared with the previous standard of care (taxane, trastuzumab and pertuzumab).

The approval expands Enhertu’s use beyond later-line settings, where it had previously earned FDA clearance, and could establish the combination as a new frontline standard of care in this aggressive oncology segment

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