For US Healthcare Professionals
A GLOBAL, PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 3 TRIAL1,2
Select eligibility criteria (n=228)1*
- Postmenopausal women and men
- ER+/HER2- advanced or metastatic breast cancer
- Progression on 1-2 lines of ET, at least one in combination with a CDK4/6i
- ≤1 line of chemotherapy for advanced or metastatic disease
- ECOG PS 0 or 1
Randomized 1:1
ORSERDU 345 mg (n=115)1
Investigator’s choice of
fulvestrant or AI (n=113)1
Fulvestrant, anastrozole, letrozole, or exemestane
Progressive disease or unacceptable toxicity
Primary endpoint
- PFS in the ESR1-mutated mBC population1†
- Median PFS
aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; ITT, intent to treat; mBC, metastatic breast cancer; PFS, progression-free survival.
*In EMERALD, both primary endpoints—PFS in the overall population (N=478) and PFS in patients with ESR1 mutations (n=228)—reached statistical significance. An exploratory analysis of PFS in patients without ESR1 mutations (n=250) indicated the improvement in the ITT population was primarily driven by outcomes in the ESR1-mutated population. FDA approval was based on the PFS results seen in patients with ESR1 mutations.1 †PFS was assessed by an independent blinded imaging review committee.1
Select Important Safety Information
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The labeling for ORSERDU contains warnings and precautions for dyslipidemia and embryo-fetal toxicity.
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The most common serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain and nausea.
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The most common adverse reactions, including laboratory abnormalities, in ≥10% of patients who received ORSERDU were musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia.
Every patient had prior ET + CDK4/6i2
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~24% of patients had primary endocrine resistance |
~25% of patients had one prior line of chemotherapy |
~24% of patients had prior fulvestrant2 |
72% of patients had visceral metastases5 |
BASELINE CHARACTERISTICS2
| ORSERDU | Fulvestrant or AI* | |||
| Parameter | ESR1-mutated mBC (n=115) | ESR1-mutated mBC (n=113) | ||
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Median age, years (range) |
64 (28-89) | 63 (32-83) | ||
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Race or ethnicity |
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| White | 89.4% | 87.0% | ||
| Asian | 5.3% | 8.7% | ||
| Hispanic | 8.7% | 8.8% | ||
| Black or African American | 4.3% | 4.3% | ||
| Other/unknown | 1.1% | 0% | ||
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ECOG PS |
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| 0 | 58.3% | 54.9% | ||
| 1 | 41.7% | 45.1% | ||
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Visceral metastases† |
70.4% | 74.3% | ||
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Prior adjuvant therapy |
53.9% | 57.5% | ||
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Prior CDK4/6i |
100% | 100% | ||
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Prior lines of ET in advanced or metastatic setting |
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| 1 | 63.5% | 61.1% | ||
| 2 | 36.5% | 38.9% | ||
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Prior lines of chemotherapy in advanced or metastatic setting |
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| 0 | 77.4% | 71.7% | ||
| 1 | 22.6% | 28.3% | ||
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Any prior ET‡ |
97.4% | 96.5% | ||
| Fulvestrant | 23.5% | 24.8% | ||
| Al | 87.8% | 85.0% | ||
At progression, your ESR1-mutated, ER+/HER2- aBC or mBC patients with these characteristics are eligible for ORSERDU§
aBC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer.
*AI therapy included either anastrozole, letrozole, or exemestane.1 †Includes lung, liver, brain, pleural, and peritoneal involvement.2 ‡Remaining patients progressed during or within 12 months of adjuvant endocrine therapy.2 §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.1
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IMPORTANT SAFETY INFORMATION
Warnings and Precautions
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Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
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Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.
Adverse Reactions
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Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
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The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).
Drug Interactions
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Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in Specific Populations
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Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
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Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
ORSERDU is available as 345 mg tablets and 86 mg tablets.
INDICATION
ORSERDU (elacestrant) 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.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 2. Bidard FC, Kaklamani VG, Neven P, et al. 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;40(28):3246-3256. 3. Kimmick G, Pilehvari A, You W, Bonilla G, Anderson R. First‑ vs second‑line CDK 4/6 inhibitor use for patients with hormone receptor positive, human epidermal growth‑factor receptor‑2 negative, metastatic breast cancer in the real world setting. Breast Cancer Res Treat. 2024;208:263-273. 4. Rugo HS, Kaklamani V, McArthur H, et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res. 2026;32(1):179-187. 5. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company
This site is intended only for US healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.
ORSERDU is a registered trademark of the Menarini Group.
© 2026 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 03/26 MAT-US-ELA-01221
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IMPORTANT SAFETY INFORMATION
+
Warnings and Precautions
-
Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
-
Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.
Adverse Reactions
-
Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
-
The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).
Drug Interactions
-
Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.
Use in Specific Populations
-
Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
-
Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).
The safety and effectiveness of ORSERDU in pediatric patients have not been established.
ORSERDU is available as 345 mg tablets and 86 mg tablets.
INDICATION
ORSERDU (elacestrant) 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.
To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 2. Bidard FC, Kaklamani VG, Neven P, et al. 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;40(28):3246-3256. 3. Kimmick G, Pilehvari A, You W, Bonilla G, Anderson R. First‑ vs second‑line CDK 4/6 inhibitor use for patients with hormone receptor positive, human epidermal growth‑factor receptor‑2 negative, metastatic breast cancer in the real world setting. Breast Cancer Res Treat. 2024;208:263-273. 4. Rugo HS, Kaklamani V, McArthur H, et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res. 2026;32(1):179-187. 5. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company