Treats postmenopausal women or adult men with estrogen … metastatic breast cancer. NDA 217639, held by Stemline Therap. Elacestrant Hydrochloride.
As of Nov 13, 2026, NDA 217639 (Orserdu), held by Stemline Therap, was first approved by FDA on Jan 27, 2023, with 2 approved supplements and 0 published complete response letters.
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, as detected by an FDA-authorized test, 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OrserduEQ 86MG BASE · tablet;oral | Elacestrant Hydrochloride | RxReference drug |
| OrserduEQ 345MG BASE · tablet;oral | Elacestrant Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2026 | Supplement 7Labeling · Standard review | Approved | |
| Nov 9, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Jan 27, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
