On January 27, 2023, the FDA approved elacestrant (OrserduTM, Stemline Therapeutics, Inc.) and a companion diagnostic test for the treatment of people with ER-positive, HER2-negative MBC with an ESR1 gene mutation who have received at least one type of hormone therapy. This approval is based on results from the phase III EMERALD clinical trial.
On February 3, 2023, the FDA expanded approval for sacituzumab govitecan (Trodelvy®, Gilead Sciences) for the treatment of people with HR-positive, HER2-negative MBC who have received at least two lines of therapy. This new approval is based on results from the phase III TROPiCS-02 clinical trial. The previous approval was only for people with triple-negative MBC who have received at least two lines of therapy.
Elacestrant (OrserduTM) for ER+, HER2- MBC
- US Food and Drug Administration: FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated MBC
Clinical Trials for Elacestrant (OrserduTM)
- Metastatic Trial Search: MBC Trials for Elacestrant (OrserduTM)
 Sacituzumab Govitecan (Trodelvy®) for HR+, HER2- MBC
- US Food and Drug Administration: FDA Approves Sacituzumab Govitecan (Trodelvy®) for HR-Positive MBC
- Gilead Sciences: FDA Approves Sacituzumab Govitecan (Trodelvy®) in Pre-Treated HR+, HER2- MBC
Clinical Trials for Sacituzumab Govitecan (Trodelvy®)
- Metastatic Trial Search: MBC Trials for Sacituzumab Govitecan (Trodelvy®)
Last Modified on September 26, 2023