美国安进地诺单抗是治什么的？

What does American Amgen treat? Amgen denosumab in the United States can be used for patients with bone metastases from solid tumors.

On December 17, 2009, the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on denosumab for the treatment of postmenopausal osteoporosis in women and hormone ablation for the treatment of prostate cancer and bone loss in men. Denosumab was approved for marketing by the European Commission on May 28, 2010.

On June 2, 2010, denosumab was approved by the United States (FDA) for use in postmenopausal women with a risk of osteoporosis. In November 2010, denosumab 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 for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or in which resection would result in significant morbidity.

Hypocalcemia must be corrected before denosumab therapy can be initiated. For patients who are prone to hypocalcemia and mineral metabolism imbalance (such as those with a history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malnutrition, small bowel resection, severe renal insufficiency), clinical monitoring of creatinine and mineral levels (such as phosphorus and magnesium) is required, and such patients should be instructed to pay attention to the symptoms of hypocalcemia and to supplement adequate amounts of calcium and vitamin D.

On May 23, 2019, China’s National Medical Products Administration announced conditional approval of the import registration application. The drug will be used to treat adults and skeletally mature adolescent patients with unresectable giant cell tumors of bone or whose surgical resection may result in severe functional impairment.

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