FDA Approves Amgen’s XGEVA Drug

The U.S. Food and Drug Administration has approved Amgen Inc.’s drug XGEVA, a bone-targeted therapy for cancer patients, the Thousand Oaks-based biotechnology company announced. The company is calling the drug the first and only inhibitor of RANK Ligand, which is believed to play a central role in cancer-induced bone destruction, for the prevention of skeletal-related events in patients with bone metastases – or the spread of cancer to bones – for solid tumors. XGEVA, also called denosumab, was approved following a 6-month priority review by the agency. “A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating,” said Kevin Sharer, Amgen’s chairman and CEO. “We are pleased to offer this new advance to patients and their healthcare providers.” The company said the agency approved XGEVA based on the results of three Phase-3 head-to-head trials that evaluate the drug delivered every four weeks. The clinical program for XGEVA spanned more than 50 tumor types in more than 5,700 patients. The company said the Phase 3 results showed XGEVA to be superior to the drug Zometa in preventing skeletal-related events for patients with breast or prostate cancer and bone metastases. The results also showed XGEVA to be non-inferior to the drug in reducing the risk of skeletal events in patients with bone metastasis due to other solid tumors or bone lesions caused from multiple myeloma. Amgen has also submitted marketing applications for XGEVA in the European Union, Australia, Canada, Switzerland and Japan.