地舒单抗什么时候上市的呢？

is an injectable agent indicated for the prevention of bone-related events in patients with bone metastases from solid tumors. Important limitations of use: Not indicated for the prevention of bone-related events in patients with multiple myeloma.

When was denosumab launched?

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. It can also be used in patients who are currently ineffective or intolerant to other treatments to reduce the risk of fractures. For the first time, denosumab was approved in 27 EU member states, as well as Norway, Iceland, and Liechtenstein.

On November 18, 2010, the US FDA approved denosumab (denosumab, trade name: Xgeva) to prevent bone-related events (SREs) in tumor patients whose cancer has metastasized and damaged bone.

In 2018, denosumab 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 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.

On May 27, 2019, Amgen China announced today that Denosumab Injection has been approved by the National Medical Products Administration for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection may cause severe functional disability, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and body weight >45 kg).

At present, it has been launched in more and more countries or regions, and it has also brought new treatment hope to more patients with bone metastases. Patients in need can contact the medical companion service to learn more about denosumab.