地诺单抗上市的日期

Denosumab was first approved in the United States in 2010 for the prevention of bone-related events in adults with bone metastases from solid tumors. In 2011, it was also approved in Europe for the same indication. As medical research advances, the U.S. Food and Drug Administration (FDA) has approved an expansion of its denosumab for the treatment of giant cell tumor of bone (GCTB) in adults and certain adolescents, making it the first drug to treat this rare disease in the United States. To this end, denosumab will provide a much-needed treatment option for patients who are inoperable or who would otherwise have to undergo extensive, life-altering surgery.

This expanded use approval was based on data from a pair of clinical trials. A total of 305 adult and adolescent patients with GCTB who either had recurrent disease or were ineligible for surgical resection were recruited. The FDA stated that among these 187 patients, tumor shrinkage was observed in 47 patients after an average of 3 months, and 51% of patients had an objective response that lasted for at least 8 months. The data also showed that GCTB re-grew in 3 patients whose tumors shrank during an average follow-up of 20 months.

Denosumab can only be given by subcutaneous injection, not intravenous infusion, intramuscular infusion or intradermal injection. Solid tumor bone metastases: 120 mg administered subcutaneously in the upper arm, thigh, or abdomen every 4 weeks. Giant cell tumor of bone: 120 mg subcutaneously every 4 weeks, followed by 120 mg on days 8 and 15 during the first month of treatment. Administer calcium and vitamin D appropriately to prevent hypocalcemia. Malignant hypercalcemia: 120 mg subcutaneously every 4 weeks, followed by a further 120 mg on days 8 and 15 during the first month of treatment. The medication is injected under the skin in the upper arm, thigh, or abdomen.

Hypocalcemia must be corrected before initiating treatment with Denosumab. 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.