Enhertu followed by THP supplemental biologics license application accepted in the US for patients with high risk HER2 positive early stage breast cancer prior to surgery

Daiichi Sankyo

1 October 2025 - Based on results from DESTINY-Breast11, the first Phase 3 trial to demonstrate benefit of Daiichi Sankyo and AstraZeneca’s Enhertu in early stage breast cancer.

Daiichi Sankyo and AstraZeneca’s supplemental biologics license application for Enhertu (trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab has been accepted for review in the US for the neo-adjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier , Registration