India, Sept. 18 -- Eli Lilly and Company (LLY) announced that the U.S. Food and Drug Administration has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, for use in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor. The treatment is approved for adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer, as identified by an FDA-authorized test, whose disease has progressed following at least one line of endocrine therapy.
This marks the second FDA approval for Inluriyo in less than a year, following its September 2025 approval as monotherapy for the treatment of adults with ER+, HER2-, ESR1-mutated MBC whose disease progressed after at least one lin...