Wire · opportunities
FDA Approves Imlunestrant Plus Abemaciclib for ESR1-Mutated Advanced Breast Cancer
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Fusion42 · 18 September 2026 · Fusion42 review
The FDA approved imlunestrant combined with abemaciclib for adults with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer after progression on endocrine therapy, supported by improved progression-free survival in the EMBER-3 trial. The Guardant360 CDx assay was also approved as a companion diagnostic to identify eligible patients.
This Wire brief sits within Fusion42's coverage of Biotech, and 10 sources have reported it between 18 Sep 2026 and 21 Sep 2026.
◆ ◆ The Wire takeaway
You can now target ESR1-mutated advanced breast cancer with a new oral combination approved by the FDA; your clinical and diagnostic approaches must adapt quickly to include Guardant360 testing to access this market.
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10 sources · first reported 18 Sep 2026 · latest 21 Sep 2026
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