Denosumab
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.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| 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) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Denosumab" OR ABSTRACT:"Denosumab" OR TITLE:"Xgeva" OR ABSTRACT:"Xgeva" OR TITLE:"Prolia" OR ABSTRACT:"Prolia" OR TITLE:"Wyost" OR ABSTRACT:"Wyost" OR TITLE:"Jubbonti" OR ABSTRACT:"Jubbonti" OR TITLE:"Osenvelt" OR ABSTRACT:"Osenvelt") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Denosumab, not a curated reading list.
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