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
- Breastcancer.org: FDA Approves OrserduTM for ER+ Metastatic Breast Cancer
- Metastatic Breast Cancer Alliance: New Drug Approved to Treat Metastatic Breast Cancer Patients with ESR1 Mutations
- US Food and Drug Administration: FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Metastatic Breast Cancer
- Healio: FDA Approves Elacestrant for Metastatic Breast Cancer
- News and Observer: Pill for Metastatic Breast Cancer Approved by FDA
Clinical Trials for Elacestrant (OrserduTM)
- Metastatic Trial Search: MBC Trials for Elacestrant (OrserduTM)
- American Society of Clinical Oncology: ASCO’s Guideline Rapid Recommendation Update for ESR1 Mutation Testing
- American Society of Clinical Oncology: Harold Burstein, MD, PhD, on ASCO Guideline Update for Elacestrant
Last Modified on September 26, 2023