Orserdu
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Elacestrant
- Made by
- Stemline Therapeutics B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (ORSERDU). It describes the substance, not this exact product.
Elacestrant is an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα).
In ER-positive (ER+) HER2-negative (HER2-) breast cancer cells, elacestrant inhibited 17β-estradiol mediated cell proliferation at concentrations inducing degradation of ERα protein mediated through proteasomal pathway.
Elacestrant is primarily metabolized by CYP3A4 and to a lesser extent by CYP2A6 and CYP2C9.
Effect of Food Administration of ORSERDU 345 mg with a high-fat meal (800 to 1000 calories, 50% fat) increased Cmax by 42% and AUC by 22% compared to fasted administration.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-24
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
Details
| Made by | Stemline Therapeutics B.V. |
|---|---|
| Active substance | Elacestrant |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L02BA · Cancer treatments and immune-system medicines |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2023-09-15 |
| Last updated by the regulator | 2026-08-04 |
| EMA product number | EMEA/H/C/005898 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).