Surgery News

Amgen granted FDA priority review designation for denosumab BLA

February 20, 2016

Bone metastases, the spread of tumors to the skeleton, are a serious concern for many patients with advanced cancer. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor, often producing serious clinical consequences such as fractures, spinal cord compression, or the need to receive radiation or surgery to bone. These events are collectively called SREs. The RANK/RANKL pathway is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. Denosumab is the first therapy to target this important pathway.

Amgen has also submitted marketing applications in the European Union, Australia, Canada and Switzerland.  In Japan, Amgen is working with our licensing partner, Daiichi-Sankyo Limited and a submission is planned in the near future.