Also known as: Orserdu
Orserdu is the brand name for elacestrant, an oral estrogen receptor antagonist approved for selected ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy progression. It is taken once daily with food and requires patient selection based on ESR1 mutation testing. Initial U.S. approval was in 2023.
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.
