# Denosumab

Source: https://onco.cc/drugs/denosumab/  
OnCo record `denosumab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Denosumab is an injection under the skin that blocks the signal driving bone breakdown. As Xgeva it prevents fractures and other bone complications in people whose cancer has spread to bone or who have myeloma; as Prolia it treats osteoporosis, including bone loss caused by hormone therapy for breast and prostate cancer.

## Summary

Denosumab (Xgeva, 120 mg monthly) was approved by the FDA in November 2010 for prevention of skeletal-related events in bone metastases from solid tumours, on three phase 3 trials against zoledronic acid in breast cancer, prostate cancer and other solid tumours in which it delayed first skeletal events at least as well as, and in breast and prostate cancer better than, the bisphosphonate. Later Xgeva indications: giant cell tumour of bone (2013), hypercalcaemia of malignancy refractory to bisphosphonates (2014) and multiple myeloma (2018). Prolia (60 mg six-monthly, 2010) treats osteoporosis and bone loss from aromatase inhibitors or androgen deprivation. The EU authorised Prolia in 2010 and Xgeva in 2011; biosimilars (Wyost/Jubbonti, Osenvelt/Stoboclo) reached the market from 2024. Osteonecrosis of the jaw, atypical femoral fractures, hypocalcaemia (boxed warning in advanced kidney disease) and rebound vertebral fractures after stopping are the key risks; unlike bisphosphonates it needs no renal dose adjustment.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Also known as: Wyost; Jubbonti; Osenvelt; Stoboclo
- Tags: nci-list; supportive
- Brand: Xgeva / Prolia
- Modality: Monoclonal antibody (anti-RANKL, fully human IgG2)
- Mechanism: Binds RANK ligand and prevents it activating RANK on osteoclasts and their precursors, suppressing bone resorption and the tumour-bone vicious cycle.
- Approvals: US 2010: Prevention of skeletal-related events in bone metastases from solid tumours (Xgeva); postmenopausal osteoporosis and treatment-induced bone loss (Prolia); US 2013: Giant cell tumour of bone; hypercalcaemia of malignancy (2014); multiple myeloma (2018); EU 2011: Prevention of skeletal-related events in bone metastases and, later, multiple myeloma; giant cell tumour of bone (Xgeva)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Denosumab
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=denosumab
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/denosumab
- EPAR (Xgeva): https://www.ema.europa.eu/en/medicines/human/EPAR/xgeva

## Connected records

- drugs: [Ibandronic acid](https://onco.cc/drugs/ibandronic-acid/), [Pamidronate](https://onco.cc/drugs/pamidronate/), [Zoledronic acid](https://onco.cc/drugs/zoledronic-acid/)
- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Osteosarcoma](https://onco.cc/cancers/osteosarcoma/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Bone after childhood cancer: peak bone mass, osteonecrosis and what rebuilds](https://onco.cc/technologies/rejuv-paed-bone/), [Bone loss caused by cancer treatment, and what rebuilds it](https://onco.cc/technologies/cancer-treatment-bone-loss/), [Bone-modifying agents (bisphosphonates, denosumab)](https://onco.cc/technologies/bone-modifying-agents/), [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [RANK ligand (RANKL)](https://onco.cc/targets/rankl/)
- companies: [Amgen](https://onco.cc/companies/amgen/)
- terms: [Bone metastases and skeletal-related events](https://onco.cc/terms/bone-metastases/), [Palliation in advanced triple-negative breast cancer: brain, bone, pleura, skin and end of life](https://onco.cc/terms/tnbc-symptom-control-palliation/), [Palliation in lung cancer: breathlessness, pleural effusion, blocked airway, bone and brain](https://onco.cc/terms/lung-palliation-breathlessness-effusion-obstruction/), [Seed and soil hypothesis of metastasis (Paget)](https://onco.cc/terms/seed-and-soil-hypothesis/)
- trials: [A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors](https://onco.cc/trials/nct07028268/), [PEACE-3 (EORTC 1333)](https://onco.cc/trials/peace-3/)

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