Regardless of how FDA handles the quality of life data in Amgen
Inc.'s BLA submission for Prolia denosumab to treat bone metastases in
cancer, the biotech hopes the findings will help unseat Zometa zoledronic acid
as standard of care. At the American
Society of Clinical Oncology meeting, Amgen presented three posters
from Phase III trials showing the mAb improved pain scores and a
patient-reported functional assessment versus Zometa.
"Zometa is an effective
agent and there is no question it works well, but we think that denosumab works
better and will represent an incremental benefit," said Roger Dansey,
executive medical director of global development at Amgen.