Articles tagged with: Xgeva

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[ by | Updated: Nov 20, 2010 3:00 p.m. | Comments Off ]
Xgeva Receives FDA Approval For Bone Disease In Solid Tumors, But Not Multiple Myeloma

The U.S. Food and Drug Administration announced earlier today that denosumab, which will be marketed by Amgen under the brand name Xgeva, has been approved to help prevent fractures and to slow bone disease in patients with solid tumors. It was not approved at this time for use in patients with multiple myeloma.

“It wasn’t approved [for myeloma] because the Xgeva-treated subset of multiple myeloma patients had more deaths than the control arm,” said Erica Jefferson, a spokesperson for the Food and Drug Administration (FDA).

Xgeva is an antibody that prevents bone …

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[ by | Updated: Nov 19, 2010 7:35 pm | Comments Off ]
Beacon BreakingNews – Xgeva Receives FDA Approval For Bone Disease In Solid Tumors, But Not Multiple Myeloma

The U.S. Food and Drug Administration announced today that it approved Amgen’s Xgeva to help prevent fractures and to slow bone disease in patients with solid tumors that have spread to and caused damage to bone. Xgeva was not approved, however, for multiple myeloma patients with bone damage.

Xgeva is the new brand name given to denosumab when used for the treatment of cancer-related bone disease. Denosumab at lower doses is marketed under the brand name Prolia for the treatment of postmenopausal women with osteoporosis and a high risk of bone fractures. …

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