What Is Orserdu (Elacestrant)? FDA Approval, Authorization and Reimbursement Status in Turkey
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Next-Generation Hormonal Therapy in Breast Cancer: Orserdu (Elacestrant)
Orserdu (Elacestrant)is intended particularly for hormone receptor-positive (ER+), HER2-negative advanced breast cancer carrying an ESR1 mutation that causes resistance to standard treatments. It is the first and only orally administered selective estrogen receptor degrader (SERD) developed for these patients. Details of this innovative drug are presented below.
Drug Profile
- Brand Name: Orserdu®
- Active Ingredient: Elacestrant
- Class: SERD (Selective Estrogen Receptor Degrader)
- Category: Antineoplastic / Hormone Antagonist
- Route of Administration: Oral Film-Coated Tablet
- Manufacturer: Stemline Therapeutics (Menarini Group)
🇹🇷 Status in Turkey (CURRENT - 2026):
- Pharmacy Availability: Available.
- Authorization in Turkey: Authorized on 26.08.2025. Therapeutic Indication: ORSERDU monotherapy is indicated for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative recurrent/metastatic breast cancer, an activating ESR1 mutation and progression after endocrine therapy containing a CDK4/6 inhibitor.
- Reimbursement (SGK): The standard reimbursement list (SUT) does not include it. SGK does not cover it directly.
- Legal Route: After an off-label-use application, patients generally obtain an “Interim Injunction” (Court Case) to have SGK pay for the drug.
- March 2026 Price: Orserdu 86 mg 28 tablets: 97631.55 TL and Orserdu 345 mg 28 tablets: 292621.51 TL.
Approved Indications
As a targeted version of hormonal therapy, Orserdu received FDA approval for the following patient group:
- Target Population: Postmenopausal women or adult men.
- Cancer Type: Estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer.
- Critical Requirement (Mutation): Genetic testing performed when the disease progresses must identify an ESR1 mutation . (Effectiveness is low if the mutation is absent.)
FDA Approval History
- October 20, 2021: The phase 3 EMERALD trial demonstrated the drug's superiority over standard treatment in controlling disease (PFS).
- August 11, 2022: The FDA granted Priority Review.
- January 30, 2023 (Official Approval): The FDA approved Orserdu for patients with ESR1-mutated breast cancer. It became the first oral SERD in this setting.
What Is Orserdu (Elacestrant) and How Does It Work?
Elacestrant does more than block estrogen receptors, the cancer cell's fuel source: it breaks them down and destroys them.
🔬 Mechanism of Action:
- Binding and Breakdown (Degradation): The drug binds to the estrogen receptor (ER) in a cancer cell and changes its shape. The cell recognizes the altered receptor as waste and breaks it down.
- Activity Against Mutations: Whereas standard hormonal drugs cannot bind to altered receptors with ESR1 mutations, elacestrant recognizes and degrades these mutant receptors as well.
- Result: The cancer cell, with its hormonal signal completely interrupted, cannot grow and dies.
Pharmacokinetic Properties
| Parameter | Feature |
|---|---|
| Absorption | Low bioavailability (~10%). Absorption increases by 42% when taken with food. |
| Distribution | Very extensive distribution throughout the body (5800 L). High protein binding (>99%). |
| Metabolism | Processed in the liver by CYP3A4 . (Critical for drug interactions.) |
| Elimination | Most (82%) is excreted in feces. Renal (urinary) elimination is minimal. Half-life is 30-50 hours. |
Administration and Dosage
Drug Interactions
⚠️ Drug Groups Requiring Attention:
- Drugs Affecting CYP3A4: Enzyme inhibitors such as ketoconazole (an antifungal) increase toxicity. Inducers such as rifampicin or St. John's wort eliminate the drug's effect.
- Stomach-Protective Drugs: Medicines that reduce stomach acid, such as omeprazole and lansoprazole, may impair Orserdu absorption. Separate them by at least 2 hours or avoid their use.
- Cardiac Drugs: ECG monitoring is essential when used with QT-prolonging drugs, such as amiodarone.
Side Effects
Possible adverse effects during treatment include:
Very Common
- Nausea (35%)
- Fatigue / Weakness (19%)
- Vomiting (12%)
- Joint and Muscle Pain (11%)
- Loss of Appetite (11%)
Requiring Monitoring
- Increased Cholesterol / Lipids (30%)
- Elevated Liver Enzymes (AST/ALT)
- Increased Creatinine (Kidney Function)
- QT Prolongation (Heart Rhythm Change - 3%)
Resistance Mechanisms
Tumor cells may eventually develop resistance to this drug as well:
- Receptor Changes: Further changes in estrogen receptor structure that prevent drug binding.
- Alternative Pathways: The tumor continues to grow through non-estrogen pathways, such as PI3K/mTOR.
- Drug Efflux: The cell increases P-glycoprotein pumps, expelling the drug.
References
- Bidard FC, Kaklamani VG, 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.
- FDA. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Jan 2023.
- Stemline Therapeutics. ORSERDU® (elacestrant) tablets: Prescribing Information. 2023.
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