Amgen gets priority review from FDA
THOUSAND OAKS, Calif. The Food and Drug Administration has given priority review to an application from Amgen for a cancer drug, the biotech company said Friday.
Amgen received the designation for denosumab, used to treat cancer that has spread to the bones and reduce the risk of bone-related injuries. Amgen filed the application for denosumab, a monoclonal antibody, in May.
The FDA gives priority-review designation to drugs thought to offer major advances in treatment or provide treatment where no adequate therapy exists.
“Many cancer patients with skeletal mestastases suffer debilitating complications despite receiving the best available therapies,” Amgen EVP research and development Roger Perlmutter said.