Posted by Michael Wonder on 25 Sep 2025
FDA approves imlunestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
25 September 2025 - Today, the FDA approved imlunestrant (Inluriyo, Eli Lilly), an oestrogen receptor antagonist, for adults with oestrogen receptor positive, human epidermal growth factor 2 negative, oestrogen receptor-1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with imlunestrant.
