首个治疗骨巨细胞瘤药物-狄诺塞麦

In June 2010, the FDA approved (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. Today we will learn more about the first drug to treat giant cell tumor of bone - denosumab.

Denosumab (denosumab) is a powerful and effective bone resorption inhibitor and a targeted treatment for osteoporosis that targets the osteoclast regulatory pathway. On May 27, 2019, Amgen China announced today that denosumab has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or that may result in severe functional disability after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

In 2018, denosumab (denosumab) was included in the list of overseas new drugs in urgent clinical need (first batch) and entered the fast 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 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%.

Recommended use of denosumab (denosumab): Malignant hypercalcemia: 120 mg subcutaneously every 4 weeks, followed by 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.

Denosumab (denosumab) is seen as one of the most important growth drivers for Amgen, the world's largest biotech company. In clinical trials of denosumab, 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. The therapeutic effect was very significant.

The above is the introduction to the drug (denosumab), I hope it can help you!