Company news: Amgen
Exceeding analyst expectations for a failure, the FDA's Oncologic Drug Advisory Committee voted 12-1 against an expanded use for Amgen's denosumab drug Xgeva. The pharma company wanted the greenlight for the drug as a preventive measure for men with castration-resistant prostate cancer, but whose cancer has not spread to the bones. A study showed the drug delayed the onset of bone tumors by just over 4 months. Xgeva is a high dose of the denosumab injection, which Amgen also markets in a lower dose as skeleton-building drug Prolia. The panel questioned the preventative value of a drug that delays cancer from spreading instead of stopping it, and was also concerned by the high rate of bone degeneration among patients with extended exposure to the drug.
Despite analyst failure expectations, the defeat still held a degree of surprise. "FDA's ODAC panel 12-1 vote against recommending approval of Xgeva sBlA was more negative than we had expected," Jefferies analyst Eun K. Yang wrote in a research note. The no votes were from the panel's 12 physicians. The lone yes was from the patient advocate, the Associated Press reported. The FDA is not bound by the panel's decision and can still support an expanded use of the drug.