ARTICLE | Product Development

Full Speed Ahead

Bone metastases and beyond: What's next in Amgen's timetable for denosumab

November 22, 2010 8:00 AM UTC

Even before FDA approved Amgen Inc.'s sBLA for denosumab to prevent skeletal related events in patients with bone metastases from solid tumors last week, the company was already moving to add more indications to the mAb's label. Indeed, pivotal data for the drug, which first entered the clinic in 2001, will keep coming for several years.

The latest sBLA was based on data from three Phase III trials comparing the human mAb targeting receptor activator of NF-kappa B ligand (RANKL; TNFSF11) with standard of care - Zometa zoledronic acid from Novartis AG. One study was in castration-resistant prostate cancer (CRPC), one in breast cancer, and one in patients with solid tumors (excluding breast and prostate cancers) or multiple myeloma (MM)...