The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for elacestrant, an investigational oral selective estrogen receptor down-regulator/degrader (SERD) as a treatment of women with ER+ and HER2- advanced or metastatic breast cancer. Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.
About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor down-regulator/degrader (SERD), which at high doses is being evaluated for potential use as an oral non-steroidal treatment for hormone-driven or hormone-resistant breast cancer. Elacestrant is currently being investigated for potential use in postmenopausal women with estrogen receptor positive breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.
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