Xgeva denosumab regulatory update

The U.K.'s NICE issued final guidance recommending the use of Xgeva denosumab from Amgen to prevent skeletal-related events (SREs) in patients with bone metastases from breast cancer; and from solid tumors other than prostate cancer if bisphosphonates would otherwise be prescribed. The recommendation is contingent on Amgen providing Xgeva at an undisclosed discount under a patient access scheme. The guidance is in line with an August final appraisal determination (FAD) (see BioCentury, Aug. 27).

Xgeva is approved in the U.S. and EU to prevent SREs in adults with bone metastases from solid tumors. The drug is also approved as Prolia in the U.S. and EU to treat osteoporosis in postmenopausal women, in the EU to treat bone loss associated with hormone ablation in men with prostate cancer, and in the U.S. to increase bone mass in men with osteoporosis at high risk for fracture (see BioCentury, Sept. 24). In April, FDA issued a complete response letter for an sBLA for Xgeva to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases (see BioCentury, April 30). ...