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It is a bone resorption inhibitor with a unique mechanism of action. It specifically targets receptor activator of nuclear factor kappa B (RANK) ligand, inhibits the activation and development of osteoclasts, reduces bone resorption, and increases bone density.

So, is denosumab on the market?

On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures.

For the first time, denosumab was approved in 27 EU member states, as well as Norway, Iceland, and Liechtenstein.

In June 2010, denosumab was approved by the FDA for marketing. Desomasumab is approved for the prevention of bone-related events with bone metastasis in solid tumors. It is not used for the prevention of bone-related events in patients with multiple myeloma. It is approved for use in adults or bone-mature adolescents with giant cell tumors of bone that are unresectable or where surgical resection may cause serious complications. It is also approved for use in hypercalcemia of malignant tumors.

Bisphosphonates are a commonly used treatment drug for patients with bone metastasis, and denosumab is a newly approved drug for the treatment of bone metastasis. Which one of them has a better therapeutic effect?

Desosumab and bisphosphonates have different mechanisms of action. In patients with existing bone metastases, denosumab appears to be more effective than zoledronic acid in preventing fractures. It can help improve bone quality even after bisphosphonates have failed.

The FDA-approved indication for the treatment of bone metastases from solid tumors is based on the results of three published pivotal clinical trials. Comprehensive analysis of these three studies showed that compared with zoledronic acid, denosumab prolonged the time to the patient's first adverse bone event (ARE) by 17%, or significantly delayed the median time to the first SRE by 8.2 months (27.6 months vs. 19.4 months), and denosumab also extended the time interval from the first SRE to the recurrence in the study by 18%;