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CHMP Recommends T-DXd Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer
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Fusion42 · 25 July 2026 · Fusion42 review
EU regulatory committee (CHMP) recommended approval of T-DXd plus pertuzumab as first-line treatment for HER2-positive metastatic breast cancer, based on DESTINY-Breast09 trial data showing 44% reduction in disease progression or death versus current standard of care. FDA approved the same combination in December 2025.
This Wire brief sits within Fusion42's coverage of Digital Health.
◆ ◆ The Wire takeaway
If you make companion diagnostics, biomarker assays, or patient monitoring tools for breast cancer, the first-line standard just shifted across both US and EU markets in the same year—your installed base needs to validate for a new drug, and hospitals will reconfigure treatment pathways. You have a six-month window to embed your test in the new protocol before reimbursement locks in.
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1 source · 25 Jul 2026
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