地诺单抗好吗？

It is the first approved monoclonal antibody that specifically targets RANK ligand and is a bone resorption inhibitor with a unique mechanism of action. On May 28, 2010, the European Commission approved denosumab for the treatment of bone loss associated with hormone suppression in postmenopausal women with osteoporosis and prostate cancer. In June of the same year, this product was approved by the FDA for marketing. November 18, 2010 FDA approved denosumab for the treatment of bone metastasis from solid tumors. Is denosumab good?

The indications for denosumab were approved 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 trials compared denosumab with zoledronic acid (a bisphosphonate) in patients with bone metastases from breast cancer, prostate cancer and other solid tumors, as well as multiple myeloma.

A comprehensive analysis of these three studies showed that compared with zoledronic acid: 1 Denosumab prolonged the time to the first adverse bone event (ARE) in patients 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). months); 2 Denosumab prolonged the time from first episode to recurrence of SRE in the study by 18%; 3 For patients with mild or no pain at study entry, denosumab also significantly prolonged the time to worsening pain compared with zoledronic acid.

It has a very good therapeutic effect and can achieve the purpose of alleviating the pain caused by bone metastasis and related complications. Based on this, the NCCN guidelines recommend the use of denosumab for patients with bone metastases from solid tumors.