How many years will denosumab last?

The US FDA approved (denosumab, trade name: Xgeva) on November 18, 2010 to prevent bone-related events (SREs) in tumor patients whose cancer has metastasized and damaged bone. So-called bone-related events include pathological fractures caused by cancer, hypercalcemia, bone surgery or radiotherapy, and spinal cord compression. However, the approved population for denosumab does not include patients with multiple myeloma or other leukemias.

Denosumab has 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. Denosumab (trade name: Prolia) was previously used to treat osteoporosis in postmenopausal women with a higher risk of fractures, with good safety and effectiveness.

Three randomized-double-blind clinical studies confirmed the safety and efficacy of denosumab, with a total of 5,723 patients participating in the studies. These studies compared denosumab with zoledronic acid in patients with breast, prostate, and various other cancers. The studies were designed to measure the time between patients ultimately suffering a fracture or spinal cord compression due to cancer, or requiring radiation or surgery to control pain. In patients with prostate cancer, denosumab delays SREs better than zoledronic acid. The median delay in SREs in patients with prostate cancer was 21 months and 17 months with zoledronic acid. In patients with breast cancer, zoledronic acid delayed SREs for a median of 26 months, whereas denosumab did not achieve this level. In patients with other solid tumors, denosumab and zoledronic acid delayed SREs by similar median times. The main solid tumors of the subjects were non-small cell lung cancer, multiple myeloma, renal cancer and small cell lung cancer.

To sum up, how long it can last depends on the patient's disease type, disease progression, absorption and tolerance capabilities, and cannot be generalized.