FDA Grants Priority Review Designation to Denosumab BLA

The US Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor manufactured by Amgen (Thousand Oaks, CA), for the treatment of bone metastases to reduce skeletal-related events (SREs) in patients with cancer. Filed in mid-May with the FDA, the biologics license application (BLA) submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies.

Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Consistent with priority review guidelines, the FDA will target an agency action within six months of the application submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of November 18.

Denosumab is the first fully human monoclonal antibody in late-stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases.

Amgen also has submitted marketing applications in the European Union, Australia, Canada, and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo Limited and a submission is planned in the near future.