地舒单抗的获批适应症有什么呢？

It is a RANK ligand (RANKL) inhibitor with a different mechanism of action than currently approved drugs that reduce skeletal complications of tumors. It is a fully humanized monoclonal antibody (IgG2 monoclonal antibody) that specifically targets receptor activator of nuclear factor-κB ligand (RANKL). It prevents RANKL from binding to its receptor substances, inhibits osteoclast activation and development, reduces bone resorption, and increases bone density.

On November 18, 2010, the FDA approved denosumab for the treatment of bone metastases from solid tumors. This indication was based on the results of a total of three published phase III pivotal clinical trials compared with zoledronic acid.

These three randomized, double-blind trials included a total of 5723 cancer patients: Trial 1 was breast cancer patients with bone metastases; Trial 2 was prostate cancer patients with bone metastases; Trial 3 was solid tumors other than breast and prostate cancer with bone metastases and multiple myeloma. The efficacy of denosumab was compared with that of zoledronic acid (a bisphosphonate) in breast cancer, prostate cancer and other solid tumors with bone metastases, as well as in multiple myeloma.

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 for zoledronic acid); denosumab prolonged the time from the first to the recurrence of SRE in the study by 18%. For patients with mild or no pain at study entry, denosumab also significantly prolonged the time to worsening pain compared with zoledronic acid. Based on this, denosumab is also recommended in NCCN guidelines for patients with bone metastases from solid tumors.

On June 13, 2013, denosumab was approved to treat adults and adolescents with giant cell tumor of bone (GCTB), a rare and usually noncancerous tumor.

On May 27, 2019, Amgen China announced that the injection 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 impairment after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and a body weight >45 kg).