XGEVA
Xgeva is a RANK ligand inhibitor used to prevent skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors. It is also indicated for the treatment of giant cell tumor of bone in adults and skeletally mature adolescents when the tumor is unresectable or surgery would result in severe morbidity. Additionally, the medication is used to manage hypercalcemia of malignancy that has not responded to bisphosphonate therapy.
How XGEVA Works
Xgeva binds to RANKL, a protein essential for the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By preventing RANKL from activating its receptor on the surface of osteoclasts and their precursors, the drug inhibits the bone breakdown and calcium release associated with various cancers. In giant cell tumors of bone, this mechanism also targets osteoclast-like giant cells to reduce osteolysis and tumor growth.
Details
- Status
- Prescription
- First Approved
- 2010-06-01
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
XGEVA Approval History
What XGEVA Treats
4 indicationsXGEVA is approved for 4 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
- Bone Metastasis
- Giant Cell Tumor of Bone
- Hypercalcemia of Malignancy
XGEVA Biosimilars
10 FDA-approved10 can be substituted at the pharmacy without calling the prescriber.
What are biosimilars? Lower-cost alternatives to XGEVA with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XGEVA FDA Label Details
ProIndications & Usage
FDA Label (PDF)Xgeva is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and i...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.