Enhertu plus pertuzumab granted priority review in the US as first-line treatment for patients with HER2 positive metastatic breast cancer

Daiichi Sankyo

24 September 2025 - Based on DESTINY-Breast09 Phase 3 trial results, which showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab with a median progression-free survival of greater than three years.

Daiichi Sankyo and AstraZeneca’s supplemental biologics license application for Enhertu (famtrastuzumab deruxtecan-nxki) in combination with pertuzumab has been accepted and granted priority review in the US for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier , Registration