Biotech giant Amgen (AMGN) said its bone drug, Xgeva, received a positive recommendation from the European Medicines Agency, putting it on the fast track for approval as a treatment for skeletal injures in adults with bone metastases from solid tumors.
The agency that reviewed the drug, called the Committee for Medicinal Products for Human Use, also recommended granting Xgeva an additional year of data and marketing exclusivity in the EU due primarily to the “significant clinical benefit” of the product compared with existing therapies.
Bone metastases occur in more than 1.5 million patients with cancer worldwide and are most commonly associated with cancers of the prostate, lung and breast, with incidence rates as high as 90% of patients with metastatic disease.
“A diagnosis of skeletal-related events associated with bone metastases is devastating for patients living with cancer, and our goal is to prevent the occurrence of these debilitating bone complications, which can disrupt a patient's life and cause disability, pain, and hospitalization,” Dr, Willard Dere, senior vice president and international chief medical officer of Amgen, said in a statement.
The recommendation by the European committee was based on three late stage trials that evaluated the drug’s effectiveness compared with Zometa at delaying skeletal injuries. In the studies, Xgeva proved to be superior to Zometa in delaying time to first on-study skeletal injuries.
Xgeva is already approved in the U.S. for the prevention of skeletal-related injuries in patients with bone metastases from solid tumors. It snagged the approval following a six months priority review by the U.S. Food and Drug Administration.
In Canada, the drug is approved for reducing the risk of developing skeletal injuries in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer and other solid tumors.
Amgen has also submitted marketing applications for Xgeva in Australia, Mexico, Russia and Switzerland. It is currently working with its licensing partner in Japan.