Wire · regulatory
FDA Approves Imlunestrant in Combination With Abemaciclib for ER-Positive, HER2 ...
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Fusion42 · 19 September 2026 · Fusion42 review
The FDA has approved imlunestrant in combination with abemaciclib for treating adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. Alongside, the Guardant360 CDx assay was authorised as a companion diagnostic to identify patients with ESR1 mutations eligible for this treatment.
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 now have a new standard-approved combination therapy and companion test for ESR1-mutated breast cancer that opens a precise treatment path and diagnostic partnership opportunities. Prioritise clinical validation with Guardant360 and consider how your biotech or healthtech platform can integrate this shift to capture oncologist and patient demand.
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10 sources · first reported 18 Sep 2026 · latest 21 Sep 2026
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