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Xgeva Approval History

FDA Approved: Yes (First approved November 18, 2010)
Brand name: Xgeva
Generic name: denosumab
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Osteolytic Bone Metastases of Solid Tumors, Osteolytic Bone Lesions of Multiple Myeloma, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy

Xgeva (denosumab) is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Xgeva is also indicated for treatment giant cell tumor of bone and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Development History and FDA Approval Process for Xgeva

DateArticle
Jan  5, 2018Approval FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
Dec  8, 2014Approval FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
Jun 13, 2013Approval FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone
Nov 19, 2010Approval FDA Approves Amgen's Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors

Further information

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