Elacestrant
Drug Details
- Generic Name
- Elacestrant
- Brand Names
- ORSERDU
- Application Number
- NDA217639
- Sponsor
- Catalent Pharma Solutions, LLC
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ELACESTRANT
Indications and Usage
1 INDICATIONS AND USAGE ORSERDU 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. ORSERDU is an estrogen receptor antagonist indicated for: 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 ( 1 )