Also known as: Inluriyo
Inluriyo (imlunestrant) is an oral estrogen receptor antagonist approved for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy. FDA approval was granted in September 2025 and includes use of a companion diagnostic assay to identify eligible ESR1-mutated patients. It is administered once daily.
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
