AI Article Synopsis
- Elacestrant (ORSERDU™) is a selective estrogen receptor degrader (SERD) developed by Stemline Therapeutics for treating estrogen receptor-positive, HER2-negative breast cancer.
- In January 2023, it received FDA approval for use in postmenopausal women or adult men with advanced or metastatic breast cancer who have ESR1 mutations and have progressed after at least one line of endocrine therapy.
- The drug is currently undergoing regulatory assessment in the EU, but its development for treating vasomotor symptoms has been halted.
Article Abstract
Elacestrant (ORSERDU™) is an orally available selective estrogen receptor degrader (SERD) being developed by Stemline Therapeutics, a subsidiary of Menarini Group, for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. In January 2023, elacestrant received its first approval for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, estrogen receptor 1 (ESR1)-mutated (as determined by a US FDA-approved test) advanced or metastatic breast cancer with disease progression following ≥ 1 line of endocrine therapy in the USA. A regulatory assessment of elacestrant for the treatment of ER-positive, HER2-negative advanced or metastatic breast cancer is currently underway in the EU. Development of elacestrant for the treatment of vasomotor symptoms has been discontinued. This article summarizes the milestones in the development of elacestrant leading to this first approval for this indication.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10667141 | PMC |
| http://dx.doi.org/10.1007/s40265-023-01861-0 | DOI Listing |
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