狄诺塞麦适用于哪些病症？

(denosumab, also known as AMG-162, trade name Prolia) 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.

What conditions is denosumab suitable for?

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. In November of the same year, based on the results of three randomized controlled phase III clinical studies, the FDA approved denosumab (trade name: Xgeva) 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 addition, Amgen is continuing to expand new indications for Denosumab. For example, in January 2018, the FDA approved Denosumab for the treatment of SREs in patients with multiple myeloma. Denosumab also received orphan drug designation for the treatment of giant cell tumor of bone and malignant hypercalcemia.

At the same time, in 2018, 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 the first and currently the only drug 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, denosumab resulted in effective long-term disease control, with a 5-year progression-free survival (PFS) rate of 88%.

On May 23, 2018, the U.S. FDA approved a new indication for Amgen, allowing the drug to be used to treat glucocorticoid-induced osteoporosis (GIOP), suitable for male and female patients at high risk of fractures.