<p>Enwylma is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone. These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery.</p><p>Enwylma is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed. It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.</p><p>Enwylma contains the active substance denosumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Enwylma is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Enwylma is Xgeva. For more information on biosimilar medicines, see <a href="https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines">here</a>.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).<br><br>Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.</p></div>
Therapeutic Area (MeSH)
ATC Code
M05BX04
ATC Item
N/A
Pharmacotherapeutic Group
Drugs for treatment of bone diseases
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| denosumab | N/A | denosumab |
EMA Name
Enwylma
Medicine Name
Enwylma
Aliases
N/ANo risk management plan link.