Difference between revisions of "Elacestrant (Orserdu)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
m
Line 4: Line 4:
 
==Diseases for which it is established==
 
==Diseases for which it is established==
 
===[[Breast cancer, ER-positive]]===
 
===[[Breast cancer, ER-positive]]===
#'''EMERALD:''' Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, García Sáenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortés J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256. Epub 2022 May 18. [https://doi.org/10.1200/jco.22.00338 link to original article] '''does not contain dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35584336/ PubMed] NCT03778931
 
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==

Revision as of 16:28, 28 January 2023

Mechanism of action

From the NCI Drug Dictionary: An orally available, selective estrogen receptor degrader (SERD) and selective estrogen receptor modulator (SERM), with potential antineoplastic and estrogen-like activities. Upon oral administration of higher doses of elacestrant, this agent acts as a SERD, which binds to the estrogen receptor (ER) and induces a conformational change that results in the degradation of the receptor. This may inhibit the growth and survival of ER-expressing cancer cells. At lower doses of this agent, RAD1901 acts as a SERM and has estrogen-like effects in certain tissues, which can both reduce hot flashes and protect against bone loss. In addition, elacestrant is able to cross the blood-brain barrier (BBB).

Diseases for which it is established

Breast cancer, ER-positive

History of changes in FDA indication

  • 1/27/2023: Approved for 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. (Based on EMERALD)

Also known as

  • Code name: RAD1901
  • Brand name: Orserdu