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New Real World Data - Expert led national broadcast. ORSERDU® (elacestrant) for patients with ESR1-mutated, ER+/HER2- mBC following progression on ET

The broadcast will focus on new data on ORSERDU. ORSERDU is indicated for postmenopausal women or adult men ER+/HER2-, ESR1 mutated advanced or metastatic breast cancer after disease progression on ET.

Key Takeaways

  • Learn about the new data on ORSERDU and implications for clinical practice

 

Please see Important Safety Information below and click here for full Prescribing Information.

All Events

New Real World Data - Expert led national broadcast. ORSERDU® (elacestrant) for patients with ESR1-mutated, ER+/HER2- mBC following progression on ET

Past Events

November

19

2025

7:00 PM - 8:00 PM Eastern Time (ET)

Virtual

December

03

2025

6:30 PM - 7:30 PM Pacific Time (PT)

Virtual

Additional Info

Faculty

Seth A. Wander, MD, PhD-Wednesday, November 19
Hope S. Rugo, MD-Wednesday, December 3


Orserdu PI

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.

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.

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.

Acknowledgement

Sponsored By

Stemline