Xgeva denosumab regulatory update

The National Comprehensive Cancer Network (NCCN) released a new guideline for patients with breast cancer that now recommends Xgeva denosumab from Amgen as an option for patients with bone metastases from solid tumors to prevent skeletal-related events (SREs). FDA approved the human mAb targeting receptor activator of NF-kappa B ligand ( RANKL; TNFSF11) for the indication last November. Denosumab is also approved in the EU for the indication and as Prolia in the U.S. and EU to treat osteoporosis in postmenopausal women and in the EU to treat bone loss associated with hormone ablation in men with prostate cancer. ...