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Live News REGULATION ARTICLE M impact

U.S. FDA approves Inluriyo with Verzenio for ER+/HER2- breast cancer

FDA approval covers Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.

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Inluriyo plus Verzenio showed proven clinical benefit after the evidence-based practice of maximizing initial treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor. In the Phase 3 EMBER-3 trial, Inluriyo in combination with Verzenio doubled median progression-free survival compared with the control arm.