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Ref Type
PMID
Authors
Title Xgeva (denosumab) FDA Drug Label
Journal
Vol
Issue
Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125320
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Denosumab Xgeva AMG162|AMG-162|AMG 162|Prolia Xgeva (denosumab) is an antibody that binds to RANKL protein, inhibiting osteoclast activity and is FDA approved for use in patients with giant cell tumor of the bone (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown bone giant cell tumor not applicable Denosumab FDA approved Actionable In a Phase II clinical trial that supported FDA approval, Xgeva (denosumab) treatment resulted in an overall objective response rate of 25% (47/187) in patients with giant cell bone tumor, with a median duration of response of 20 months among patients demonstrating response (PMID: 25617146). detail... 25617146