Enhertu plus pertuzumab type II variation application validated in the EU as first-line treatment of patients with HER2 positive metastatic breast vancer

Daiichi Sankyo

19 January 2026 - Based on DESTINY-Breast09 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu in combination with pertuzumab significantly improved progression-free survival versus current first-line standard of care in HER2 positive metastatic breast cancer.

The EMA has validated the type II variation marketing authorisation application for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

Read Daiichi Sankyo press release

Michael Wonder

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Michael Wonder