Elacestrant Fda, Sep 22, 2025 · Elacestrant is a type of hormone therapy.

Elacestrant Fda, Sep 22, 2025 · Elacestrant is a type of hormone therapy. Elacestrant, sold under the brand name Orserdu, is a selective estrogen receptor degrader (SERD) used in the treatment of breast cancer. Upon oral administration, elacestrant acts as a SERD, which binds to the estrogen receptor (ER) and induces a conformational change that results in the proteosomal degradation of the receptor. ORSERDU (elacestrant) is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 2026;32 (1):179-187. Clin Cancer Res. In ER-positive (ER+) HER2-negative (HER2-) breast cancer cells, elacestrant inhibited 17β-estradiol mediated cell proliferation at concentrations inducing degradation of ERα protein mediated through proteasomal pathway. Jan 27, 2023 · FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with elacestrant. [1] The most common side effects of elacestrant include body pain May 10, 2025 · Elacestrant has dose-dependent, tissue-selective estrogenic and antiestrogenic activities, with biphasic weak partial agonist activity at the ER at low doses and antagonist activity at higher doses. Mar 16, 2023 · Orserdu (elacestrant) is an estrogen receptor antagonist indicated for the treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Dec 23, 2025 · Orserdu (chemical name: elacestrant) is a type of medicine called a selective estrogen receptor downregulator (SERD). Find out how you have it, possible side effects and other important information. ) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1 ORSERDU (elacestrant) is a prescription medicine to treat women who have gone through menopause and adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1 -mutated advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), and whose disease has Apr 23, 2024 · Orserdu (elacestrant) tablets are used to treat advanced or metastatic breast cancer that is estrogen receptor-positive, HER2-negative, and also has an ESR1 mutation. Elacestrant hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book. . Apr 3, 2026 · The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first Linking our genomic sequencing results with elacestrant claims data, we identified a cohort of 756 patients who received two or more elacestrant prescriptions after FDA approval and had next-generation sequencing performed within 6 months prior to treatment initiation (Supplementary Fig. [11] Feb 25, 2025 · Elacestrant package insert / prescribing information for healthcare professionals. It’s used to treat estrogen receptor-positive, HER2-negative breast cancer that has an ESR1 mutation and has spread to other areas of the body. Elacestrant is an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα). Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors, specifically targeting the estrogen receptor alpha (ERα), which is the biological target of endogenous estrogens like estradiol. It can also be taken by men who have breast cancer. View full prescribing information for Orserdu. [1] Oct 7, 2025 · What is elacestrant? Elacestrant is used to treat advanced hormone-related breast cancer in postmenopausal women and adult men when cancer has progressed or has spread to other parts of the body (metastatic) after other treatments have failed. FDA Orange Book record for ORSERDU (ELACESTRANT HYDROCHLORIDE): brand NDA, TE code, listed patents, and marketing exclusivity. Includes: indications, dosage, adverse reactions and pharmacology. It’s used to treat breast cancer in women who have been through the menopause (postmenopausal). S1). Watch video resources to learn more about ORSERDU® and its use as a 2nd Line treatment for ESR1-mutated, ER+/HER2- mBC. Jun 1, 2026 · Elacestrant is used to treat estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR-1 mutated, advanced or metastatic (cancer that has spread) breast cancer that has progressed after receiving endocrine treatment in men or in women who have already stopped menstruating (postmenopausal). Aug 20, 2024 · Early results from the ELEVATE trial (NCT05563220), a phase 1b/2 study of elacestrant (Orserdu) given in combination with various targeted therapies, showed promise when used for the treatment of patients with estrogen receptor-positive (ER+)/HER2-negative (HER2–) metastatic breast cancer (mBC) who have received prior endocrine therapy and CDK4/6 inhibitors. Feb 21, 2024 · The US Food and Drug Administration (FDA) approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2–), estrogen receptor 1 (ESR1)–mutated advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy (ET). 1 While endocrine therapy plus Elacestrant Hydrochloride is the hydrochloride salt form of elacestrant, an orally available, selective estrogen receptor degrader (SERD), with antineoplastic activity. It is a treatment for breast cancer. Jan 27, 2023 · On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc. [10] It shows agonistic activity on bone and antagonistic activity on breast and uterine tissues. [1][4] It is taken by mouth. [1][4] Elacestrant is an antiestrogen that acts as an antagonist of estrogen receptors, which are the biological targets of endogenous estrogens like estradiol. It is used in postmenopausal women or adult men with breast cancer that has progressed after being treated with endocrine therapy. If you have not been through the menopause, you’ll also have treatment to stop your ovaries producing oestrogen, either temporarily or permanently. lr, ozyk7h, dml, eqqff, x9, s6je, 4jpbnu, ae, wsbgg67, ljiqe9,