What is ORSERDU prescribed for?
For treatment of postmenopausal women or adult men, with ERpositive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
What is the name of the drug and what does it do?
ORSERDU (generic name: elacestrant), pronounced “or-SER-doo,” is a medication for treating a certain type of advanced breast cancer in postmenopausal women and adult men who have already undergone endocrine therapy.
Postmenopausal refers to the stage after a woman has stopped menstruating, typically around the age of 50. Endocrine therapy is a type of treatment that targets hormones or their receptors to stop or slow down the growth of hormone-sensitive tumors.
How does it work?
ORSERDU works by blocking certain pathways in the body that help hormone-responsive breast cancer cells grow and spread.
By stopping these pathways, ORSERDU helps slow down or stop the cancer cells from growing in postmenopausal women and adult men with a specific type of breast cancer.
What did the research discover?
The FDA approved ORSERDU after a clinical trial involving 478 patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
Among them, 228 had ESR1 mutations. The trial took place in 150 sites across 17 countries.
Patients had disease progression after at least one line of endocrine therapy. The safety group included 467 patients who received the drug.
Patients were randomized to receive ORSERDU or another endocrine therapy. The primary measure was progression-free survival (PFS) assessed by a review committee.
What are some of the side effects?
The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.
- Muscle and joint (musculoskeletal) pain
- Nausea
- Increased cholesterol and triglyceride levels in the blood
- Increased liver enzymes
- Tiredness
- Decreased hemoglobin
- Vomiting
- Decreased sodium levels in the blood
- Increased blood creatinine level
- Decreased appetite
- Diarrhea
- Headache
- Constipation
- Stomach-area (abdominal) pain
- Hot flush
- Heartburn or indigestion
What are the dosage recommendations and how is it prescribed?
The recommended dosage of ODSERDU is a 345 mg tablet and it should be taken once a day with food.
Source:
Drug Trials Snapshots: ORSERDU [Internet]. U.S. Food and Drug Administration. 2023 [cited 2024 Jun 28]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-orserdu
