Enhertu granted priority review in the US as post-neoadjuvant treatment for patients with HER2 positive early breast cancer

Daiichi Sankyo

9 March 2026 - Based on DESTINY-Breast05 Phase 3 trial results, which showed Enhertu reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine.

Daiichi Sankyo and AstraZeneca’s supplemental biologics license application for Enhertu (famtrastuzumab deruxtecan-nxki) has been accepted and granted priority review in the US for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in situ hybridisation positive) breast cancer who have residual invasive disease after neo-adjuvant HER2 targeted treatment.

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder