This approval process just got a positive reinforcement when Amgen said in a statement late Tuesday that denosumab worked better than Zometa from Novartis AG (NVS). Amgen said Phase III trial of denosumab showed that it was better at reducing or delaying bone problems in breast-cancer patients than Zometa. It's not surprising then that stock is surging over 15 percent in today's trading.
"We are extremely pleased with the outcome of this important study, which shows that denosumab can reduce or delay the serious complications of bone metastases in breast cancer patients better than the current standard of care, and with a favorable benefit/risk profile," said
Amgen will announce the results of a second Phase 3 trial later in the year, but noted that "osteonecrosis of the jaw (ONJ), which had not been observed in previously reported Phase 3 studies with denosumab, was seen infrequently in both treatment groups." Over 11,000 patients have been enrolled in the denosumab oncology clinical trials testing the drug for bone loss and destruction associated with cancer treatment-induced bone loss in breast and prostate cancers.
U.S. patients with bone metastases incurred
As I mentioned when the first quarter results were out, "Denosumab is also being tested for other cancer, and results from clinical trials should come in the next quarter." As Amgen noted in the statement, bone metastases are a significant problem for patients with certain types of advanced cancer, with incidence rates of nearly 100 percent in myeloma patients and as high as 75 percent in breast and prostate cancer patients. This study, experts believe, is a good indicator for other cancers.
For now, the company is seeking approval for osteoporosis and breast cancer and is scheduled to meet with a Food and Drug Administration panel on Aug. 13 to review its marketing application. The FDA is scheduled to make a decision by October.Denosumab is a genetically engineered 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). This could be a new standard of care for patients. Amgen is studying denosumab in numerous tumor types.
Interestingly, despite the possible competition, Novartis shares are also up today.