FDA Approves Imlunestrant for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer

On September 25, the FDA approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor-positive, human epidermal growth factor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

For more information, read the FDA announcement and the Eli Lilly and Company press release.

Posted on 9/26/2025