FDA Approves Combination Therapy for ESR1-Mutated Metastatic Breast Cancer

The FDA has approved imlunestrant in combination with abemaciclib for patients with ESR1-mutated, estrogen receptor–positive, HER2-negative metastatic breast cancer. This approval addresses a critical unmet need for patients who may not respond durably to existing endocrine monotherapies. The decision is based on the phase 3 EMBER-3 trial, which demonstrated a progression-free survival benefit with the new combination.