The FDA granted full approval on September 18 to imlunestrant, sold as Inluriyo, in combination with abemaciclib, sold as Verzenio, for adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The agency approved imlunestrant in combination with abemaciclib only for patients whose ESR1 mutation is identified by an FDA-authorized test.
The agency also approved the Guardant360 CDx assay as the companion diagnostic for selecting patients. Both drugs are made by Eli Lilly and Company.
