Amgen drug may aid in treatment of prostate cancer





An Amgen drug recently approved to treat osteoporosis and reduce bone complications for cancer patients could offer hope to patients with prostate cancer.

The Thousand Oaks biotech company announced last week that a study found denosumab, marketed under the brand name XGEVA, delayed the spread of cancer to the bones of prostate cancer patients by more than four months—more good news for a company that’s gone through a mostly difficult year.

Trish Hawkins, Amgen spokesperson, said the results are a “landmark.”

“This the first time that a therapy has been shown to significantly delay prostate cancer from spreading to the bone. No other product has been able to successfully demonstrate a result in this setting,” Hawkins said in an e-mail.

The Amgen-sponsored study, conducted in partnership with physicians at medical research institutions across the country, began in 2008 with 1,432 men with prostate cancer who, despite surgical or pharmacological castration, were at high risk of the cancer spreading to the bone. The study ended earlier this month.

The most common site advanced cancer spreads, or metastasizes, to is the bone. Hawkins said. As many as three out of four patients with advanced prostate cancer will develop bone metastases, which weaken the bone. Tumors stimulate bone degeneration, creating room for the tumor to grow and, in turn, allowing more bone deterioration.

In the two-year trial, half of the men received XGEVA and the other half a placebo. The study found that XGEVA blocked the tumor’s ability to stimulate bone degeneration and slowed tumor growth, Hawkins said.

In November, the U.S. Food and Drug Administration approved XGEVA for reducing the risk of bone complications in cancer patients. That was the second FDA approval in six months for the protein, which is made from a human antibody. In June, the FDA approved the drug to treat osteoporosis in post-menopausal women.

XGEVA does have side effects, although overall adverse effects were similar with the placebo. XGEVA can cause lower than normal calcium levels known as hypocalcemia and bone death due to poor blood supply, called osteonecrosis of the jaw.

Hawkins said the next step for the company is to submit the study for review at a medical meeting next year. The company also plans to discuss the results with the FDA and other regulatory agencies, although it’s unclear when.

“We cannot speculate on the outcome of those discussions and plan to address any questions they may have,” Hawkins said.

The wholesale cost of XGEVA is $1,650 a month.

For the third quarter of 2010, the biotech giant reported an adjusted net income of $1.313 billion, down 14 percent on a yearover year basis.

Amgen stocks did see a slight boost following news of denosumab’s latest test results.

At the close of trading Wednesday on Wall Street, Amgen shares were trading at $56.95 apiece.

Amgen is the largest private employer in the city of Thousand Oaks and in Ventura County. They are a large contributor to the city in three areas: sales tax, business and licensing fees, and property tax.



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