狄诺塞麦上市了吗？

(Denosumab) can not only reduce bone phosphorus release in patients with osteoporosis, but also improve kidney function. Professor Masaaki Inaba of Osaka City University in Japan and others have found through research that administering the bone resorption inhibitor denosumab (denosumab) to osteoporosis patients with normal kidney function can reduce phosphorus release in bones. Not only can it prevent the decline in kidney function that occurs with age, but it has also been found that it can further improve kidney function.

So is denosumab (denosumab) on the market?

In June 2010, the FDA approved denosumab (denosumab) for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of osteoporosis in men, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer. In November of the same year, based on the results of three randomized controlled phase III clinical studies, the FDA approved denosumab (denosumab) for the treatment of bone-related events in patients with solid tumor bone metastases, and was later approved for the treatment of giant cell tumor of bone and malignant hypercalcemia.

In 2018, denosumab (denosumab) injection was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the rapid review channel of the National Medical Products Administration. This approval makes denosumab (denosumab) the first and currently the only drug approved for the treatment of giant cell tumor of bone.

On May 27, 2019, denosumab (denosumab) was approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or where surgical resection may cause severe functional disability, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

The approval of denosumab (denosumab) is based on the results of two open-label trials in patients with recurrent, unresectable giant cell tumor of bone or in whom planned surgical resection is likely to cause severe functional disability. The latest analysis of the study, presented at the European Society for Medical Oncology (ESMO) Annual Meeting in 2017, showed that among patients who could be surgically resected, 80% improved after treatment with neoadjuvant denosumab (denosumab): 44% underwent surgery with less impact on function, and 37% avoided surgery. In patients with unresectable disease, denosumab resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%. This is good news for patients.

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