Drugs
Imlunestrant: First Approval
Keam SJ
In September 2025, imlunestrant was approved for the treatment of adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy in the USA. This article summarizes the milestones in the development of imlunestrant leading to this first approval for use in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.
Previous Article
- • Imlunestrant with or without Abemaciclib in Advanced Breast Cancer
- • Imlunestrant Monotherapy: Phase 1a/1b EMBER Study
- • Characterization of Imlunestrant as an Oral, Brain-Penetrant SERD
- • Pharmacodynamics from EMBER-2
- • Imlunestrant: First Approval
- • Imlunestrant Overcomes ESR1 Mutant Resistance in ER-Positive Breast Cancer
- • ESR1 Mutations in Breast Cancer
