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U.S. FDA approves Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for ...
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Fusion42 · 18 September 2026 · Fusion42 review
The U.S. FDA has granted full approval to Inluriyo (imlunestrant) combined with Verzenio (abemaciclib) for treating adults with ER+, HER2–, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. This approval is supported by Phase 3 EMBER-3 trial results showing doubled median progression-free survival with the combination versus Inluriyo alone.
This Wire brief sits within Fusion42's coverage of Biotech, and 10 sources have reported it between 18 Sep 2026 and 21 Sep 2026.
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You gain access to a validated FDA pathway for combining ER antagonists with CDK4/6 inhibitors in ESR1-mutated breast cancer, opening a clearer clinical development route and competitive positioning in oncology drug development.
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10 sources · first reported 18 Sep 2026 · latest 21 Sep 2026
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