FDA Grants priority review for Amgen's denosumab BLA for the reduction of skeletal-related events in advanced cancer patients

The US Food and Drug Administration has granted priority review designation to biotechnology major Amgen's denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer.

The drug, which is co-marketed with UK drugs giant GlaxoSmithKline as Prolia, (denosumab), was approved by the FDA last month as an injectable treatment for postmenopausal women with osteoporosis at high risk for fractures, some two months earlier than had been expected and just days after the drug was cleared for marketing in Europe (The Pharma Letters June 2 and May 28) and has been forecast as generating peak sales of as much as $6 billion.

Filed in mid-May with the FDA, the latest Biologics License Application (BLA) submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three pivotal Phase III head-to-head trials versus Zometa (zoledronic acid).