Drug updated on 4/16/2024
| Dosage Form | Tablet (oral; 86mg, 345 mg) |
| Drug Class | Estrogen receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Summary
- Elacestrant (Orserdu) is indicated for the treatment of postmenopausal women or adult men with ER positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have experienced disease progression following at least one line of endocrine therapy.
- The information was derived from a single study which is a Randomized Controlled Trial.
- Elacestrant demonstrated significant improvement in progression-free survival compared to the Standard of Care (SOC) endocrine monotherapy. This improvement was more pronounced in patients with detectable ESR1 mutations.
- The safety profile showed that grade 3/4 adverse events occurred more frequently in patients receiving elacestrant than those receiving SOC. Treatment-related adverse events leading to discontinuation were also slightly higher but manageable with elacestrant.
- A notable consideration from this trial is the pronounced benefit of elacestrant in patients with ESR1 mutations. These mutations are associated with resistance to standard endocrine treatments, highlighting the potential efficacy of Orserdu against such resistance mechanisms.
- Despite a somewhat higher risk for severe side effects and treatment discontinuations due to these side effects, Orserdu's safety profile remains manageable, making it an effective alternative, especially for patients harboring ESR1 mutations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Orserdu (elacestrant) Prescribing Information. | 2023 | Stemline Therapeutics, Inc., New York, NY |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| 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. | 477Subjects F: 99% M: 1% | 2022 | Journal of Clinical Oncology |
Sex Distribution:
F:99%
M:1%
477Subjects
Year:
2022
Source:Journal of Clinical Oncology