Denosumab (Xgeva, Prolia)

Immunotherapy · Approved since 2010

FDA Approved

med_ema_approved

med_spain_funded_sns med_crc_other_indication Subcutaneous 2 Clinical Trials

RANKL

Description

Denosumab is a fully human monoclonal antibody that functions as a bone-modifying agent, primarily used in colorectal cancer patients to manage bone-related complications and hypercalcemia of malignancy. This medication is particularly valuable for CRC patients who develop bone metastases or cancer-related hypercalcemia, conditions that can cause significant morbidity including bone pain, fractures, and metabolic disturbances. Denosumab provides an alternative to bisphosphonates for patients who cannot tolerate those medications or have renal impairment.

Mechanism of Action

Denosumab specifically binds to and inhibits RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), a protein essential for the formation, function, and survival of osteoclasts. By blocking RANKL, denosumab prevents osteoclast-mediated bone resorption, thereby reducing skeletal-related events and helping to normalize elevated serum calcium levels in patients with malignancy-associated hypercalcemia.

Molecular Targets

RANKL

Side Effects

Hypocalcemia Fatigue Hypophosphatemia Nausea Decreased appetite Shortness of breath Osteonecrosis of the jaw Atypical femoral fractures

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT04907539 med_phase_prefix2

Archived

A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC)

United States, South Korea, Spain, United Kingdom

NCT00896454 med_phase_prefix2

Archived

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

United States, Canada, France, Italy, Poland

Quick Info

Brand Name	Xgeva, Prolia
Category	Immunotherapy
Status	FDA Approved
Estado EMA	med_ema_approved
Acceso España	med_spain_funded_sns med_crc_other_indication
Administration	Subcutaneous
Year Approved	2010
Clinical Trials	2

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Medical Disclaimer

This information is for educational purposes only and should not replace professional medical advice. Always consult your healthcare team before making treatment decisions.