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Also called denosumab, it is a powerful and effective bone resorption inhibitor and a targeted treatment drug for osteoporosis that targets the osteoclast regulatory pathway. In June 2010, the FDA approved denosumab (trade name: Prolia) for the treatment of osteoporosis in postmenopausal women, and was later approved for the treatment of male osteoporosis, bone loss caused by androgen deprivation therapy for prostate cancer, and bone loss caused by aromatase inhibitor therapy for breast cancer.
On May 27, 2019, Amgen China announced today that Denosumab Injection has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection may lead to severe functional impairment, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg). In 2018, denosumab 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 the first and currently the only drug in China for the treatment of giant cell tumor of bone, bringing patients an innovative treatment option to control disease progression and improve quality of life.
The approval of 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 receiving neoadjuvant denosumab: 44% underwent surgery with less impact on function, and 37% avoided surgery. In unresectable patients, it resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.
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