Denosumab wins approval from the FDA after a 6-month priority review
Denosumab, a monoclonal antibody that has proved effective in preventing bone fractures and bone pain for patients whose cancer has metastasized and damaged the bone, won approval from the FDA after a 6-month priority review. Amgen is marketing the drug under the name Xgeva.
Xgeva works by binding to RANK ligand, a protein that promotes the growth and function of osteoclast cells to break down bone, thus inhibiting the ability to cause destruction, Amgen said in a press release hailing the FDA approval. The drug is administered by subcutaneous injection in 120-mg doses every 4 weeks.
“Xgeva has a different mechanism of action than currently approved drugs aimed at reducing bone complications from cancer,” Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in announcing the Nov. 19 decision.
Two other drugs, zoledronic acid (Zometa) and pamidronate disodium (Aredia) are approved for similar conditions, the FDA said.
The agency said that Xgeva was approved on the basis of 3 randomized, double-blind clinical studies in 5723 patients comparing Xgeva with Zometa. One trial consisted of breast cancer patients, another involved prostate cancer patients, and the third included patients with a variety of cancers.
David H. Henry, MD, clinical professor of medicine, and vice chair, Department of Medicine, Pennsylvania Hospital, University of Pennsylvania Healthcare System, Philadelphia, said Xgeva would become “a mainstay of cancer care.”
“As many as 3 out of 4 patients with advanced prostate, lung, and breast cancer will experience spread to their bones. Despite the availability of current treatments, a significant proportion of these patients still experience bone complications or are not candidates for existing treatment,” Henry said in an Amgen press release.
Although the label changes are shaping up as a result of the recent law, federal officials say they also are part of a wider government attack on cigarette smoking that includes more support for cessation programs, more aggressive enforcement of illegal tobacco sales to minors, and a 62-cent increase in the federal cigarette tax to more than $1.
More Info» http://tinyurl.com/3ag7an8 com/2ebl48y or Amgen at www.amgen.com
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