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U.S. FDA approves Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer
The FDA granted full approval to Lilly's oral ER antagonist Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The approval is based on the Phase 3 EMBER-3 trial.
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Inluriyo plus Verzenio delivers 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 to Inluriyo alone, among patients with ESR1 -mutated MBC The all-oral combination of Inluriyo and Verzenio gives patients a treatment approach that targets the two central drivers of ER+ breast cancer, with an established tolerability profile and no new monitoring required INDIANAPOLIS , Sept. 1…