美国安进地舒单抗注射液适应症

Indications for Amgen Injection in the United States: Desosumab Xgeva can be used in patients with bone metastases from solid tumors.

On December 17, 2009, the European Committee for Medicinal Products for Human Use issued a positive opinion on denosumab Xgeva: denosumab Xgeva is used to treat postmenopausal osteoporosis in women and to treat prostate cancer through hormone ablation to treat bone loss in men. Desosumab Xgeva was approved for marketing by the European Commission on May 28, 2010. On June 2, 2010, denosumab Xgeva was approved by the United States (FDA) for use in postmenopausal women with a risk of osteoporosis.

In November 2010, denosumab Xgeva was approved for the prevention of bone-related events in patients and the treatment of solid tumors with bone metastases. On June 13, 2013, the U.S. Food and Drug Administration approved denosumab Xgeva for the treatment of adults and skeletally mature adolescents with giant cell tumors of bone that are unresectable or in which resection would result in significant morbidity. 

In a phase II clinical trial of denosumab Xgeva, 282 patients were divided into 3 groups. Group 1 was patients with unresectable giant cell tumor of bone GCTB, group 2 was patients with postoperative giant cell tumor of bone GCTB with severe surgical complications, and group 3 was patients who had previously used denosumab Xgeva. In group 1, 96% of patients did not progress after 13 months of follow-up. After 9.2 months of follow-up in group 2, 74% of patients did not undergo surgery, and 62% of patients underwent surgery with fewer complications. The pain was significantly reduced after 2 months of using denosumab Xgeva.

Desosumab Xgeva is produced by Amgen in the United States. Amgen is the world's leading innovative biopharmaceutical R&D and manufacturing company. It takes "drug innovation" as its core concept and attaches great importance to the accumulation of R&D capabilities. It has achieved major breakthroughs in the fields of human genome, tumor biology, neuroscience, hematology and other fields.

The above is the introduction to Xgeva. If patients have other questions about denosumab Xgeva (such as drug prices, purchase channels, etc.), they can consult the medical companion travel service.

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