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Amgen Cancer Drug Xgeva Faces Scrutiny for New Use


While the drug did slow the spread of cancer, it didn't extend lives of patients in a study, FDA staff says in a report. The biotech faces a panel of government advisers who will vet trial data Wednesday.

Amgen (AMGN) likely faces some tough questions this week from government expert advisers as the company tries to win approval to market the drug Xgeva as a therapy to prevent prostate cancer from jumping to a patient's bones.

Food and Drug Administration staff was critical of the drug in documents released today. The staff cited potential toxicity and noted that the drug hasn't been shown to extend lives of patients treated in a company study.

"Treatment with (the drug) did not result in an improvement in overall survival," FDA staffers noted in briefing documents for a Wednesday advisory panel of the agency.

What's more the drug, known chemically as denosumab, poses safety questions.

"The risk-benefit ratio of denosumab must take into account the overall toxicity," the staff wrote.

The expert advisers will spend the day Wednesday considering whether Amgen's drug should be approved for the new use and will make a recommendation to the FDA, which is scheduled to make a decision by late April.

But the staff report was critical of the data and questioned the meaningfulness of the Amgen study's goal, says ISI Group analyst Mark Schoenebaum. The concern about the drug's safety is another potential roadblock, he says.

Even if the drug gets a thumbs up from the panel and, ultimately, FDA approval, Schoenebaum questions whether enough doctors would use it to treat prostate cancer patients so that it would be a meaningful contributor to Amgen's revenue.

"Commercial demand could be modest," he says, suggesting that market clearance may eventually add $300 million in sales.

Amgen is looking to build on a drug that already is expected to reach blockbuster status in the next few years. Xgeva was approved to treat bone fractures and pain caused by cancer in 2010. Amgen recorded a little more than $350 million in sales from the drug last year. Known chemically as denosumab, the drug also is sold by Amgen under the brand name Prolia. That brand generated more than $200 million in sales last year.

In a statement, Amgen stressed that there is no treatment to help stop or delay the spread of cancer -- or metastases -- to the bones in prostate cancer patients. Specifically, Amgen aims to treat men whose cancer can't be treated by hormonal therapies or surgery. The condition is known as castrate resistant prostate cancer, or CRPC, and men with this advanced form of the disease would have a new treatment option with approval, the company says.

"The development of metastatic disease in men with CRPC is a life-changing event, typically dominated by bone metastases, which are irreversible and progressive, and contribute major morbidity to these patients," Amgen says. " If approved in this expanded indication, Xgeva would become the first therapy licensed to delay the spread of cancer to bone."

Shares of Amgen fell 2% to $67.95 in late-morning trading Monday. The stock is up more than 30% over the past six months.

Twitter: @brettchase

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