New ESR1 Biomarker Research Leads to FDA Approval for ER+, HER2- MBC with an ESR1 Mutation - Metastatic Breast Cancer Trial Talk

Research News

At the end of January 2023, the FDA approved a new drug called elacestrant (OrserduTM) for people with estrogen receptor-positive, HER2-negative MBC with an ESR1 gene mutation who have received at least one type of hormone therapy. Elacestrant is taken by mouth. The FDA also approved a blood test called Guardant360 that identifies people with the ESR1 mutation who are likely to benefit from elacestrant.

In a recent post, we highlighted a study reporting that there is not enough evidence to use ESR1 mutations to guide treatment selection. However, new clinical trial data now support ESR1 mutations as a biomarker for selecting treatment with elacestrant.

Click the links below to learn more about this newly approved MBC treatment option.

Elacestrant (OrserduTM) for ER+, HER2- MBC with an ESR1 Mutation
Clinical Trials for Elacestrant (OrserduTM)


Last Modified on January 2, 2024



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