Orserdu FDA Approval History
Last updated by Judith Stewart, BPharm on March 16, 2023.
FDA Approved: Yes (First approved January 27, 2023)
Brand name: Orserdu
Generic name: elacestrant
Dosage form: Tablets
Company: Menarini Group
Treatment for: Breast Cancer
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.
- Estrogen receptor 1 (ESR1) mutations, present in up to 40% of ER+, HER2- advanced or metastatic breast cancers, are a known driver of resistance to standard endocrine therapy.
- Orserdu is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It works by binding to estrogen receptor-alpha (ERα) to block the transcriptional activity of the ER and promote its degradation.
- Orserdu tablets are taken orally, once daily, with food.
- Warnings and precautions associated with Orserdu include dyslipidemia and embryo-fetal toxicity.
- Common adverse reactions include musculoskeletal pain, nausea, fatigue, vomiting, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia. Common laboratory abnormalities include increased cholesterol, increased AST, increased triglycerides, decreased hemoglobin increased ALT, decreased sodium, and increased creatinine.
Development timeline for Orserdu
Further information
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