BLA Submitted for Denosumab

Article

Amgen Inc announced submission of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for denosumab, an investigational RANK ligand inhibitor.

Amgen Inc announced submission of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for denosumab, an investigational RANK ligand inhibitor. Amgen is seeking FDA approval for treatment and prevention of postmenopausal osteoporosis in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase III trials involving more than 11,000 patients.

 

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
4 experts in this video
4 experts in this video
Those being treated for peritoneal carcinomatosis may not have to experience the complication rates or prolonged recovery associated with surgical options.
For patients with peritoneal carcinomatosis, integrating PIPAC into a treatment regimen does not interrupt their systemic therapy.
2 experts in this video