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FDA approves imlunestrant plus abemaciclib for ESR1-mutated breast cancer
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Fusion42 · 19 September 2026 · Fusion42 review
The FDA has granted full approval for the combination of imlunestrant and abemaciclib (Inluriyo plus Verzenio) to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following at least one prior endocrine therapy line.
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 must update your oncology drug strategy to include this fully approved oral combo targeting ESR1 mutations at progression. Early adoption might ease entry barriers for patients needing dual endocrine and CDK4/6 blockade.
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10 sources · first reported 18 Sep 2026 · latest 21 Sep 2026
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