Denosumab Disapproved by FDA as Metastases Prostate Cancer Drug

April 28, 2012 by  
Filed under Prostate Cancer News

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A lot of enthusiasm and hope greeted the indication that Denosumab (a novel bone treatment drug) can be used to delay metastases prostate cancer by at least 4 months.   However, a new research by the Food and Drug Administration (FDA) showed that the risks of using this drug far outweigh the benefits. Hence the overall survival of those administered with it is low. Based on this discovery, the FDA Oncologic Drugs Advisory Committee voted against approval of it as a treatment option for bone metastases in prostate cancer. The extract below provides details on this latest development in prostate cancer treatment:

A new indication for the novel bone drug Denosumab (Xgeva, Amgen) — delaying bone metastases in men with prostate cancer at high risk for this complication — cannot be approved, according to the US Food and Drug Administration (FDA).

Denosumab is already approved for use in prostate cancer other solid tumors in patients with bone metastases, where it is used to prevent skeletal-related events, including pathologic fracture, radiation or surgery to bone, and spinal cord compression. This indication was approved in the United States in November 2010 and in Europe in June 2011.

The new indication, which has just stalled, covers the use of the drug at an earlier stage of disease — in men with castration-resistant prostate cancer who are at high risk of developing bone metastases. A pivotal clinical trial showed that denosumab can significantly delay time to the development of bone metastases in such patients, compared with placebo (25.2 vs 29.5 months), although there was no difference in overall survival.

When these results were first presented, they were greeted with enthusiasm by cancer experts; one described the data as a “paradigm shift.”

However, when these data were reviewed earlier this year by the FDA Oncologic Drugs Advisory Committee, there was somewhat less enthusiasm. The magnitude of benefit (i.e., delaying bone metastases by 4 months) was described as “quite low,” and there was discussion about whether it was clinically meaningful, considering the lack of effect on the overall course of disease and on overall survival.

The committee voted 12 to 1 against recommending the new indication for approval, saying that the benefit was outweighed by the potential risks of treatment (which include jaw osteonecrosis, seen in 5% of patients).

The FDA has followed the committee’s guidance. In a complete response letter to the manufacturer, the agency said that it “cannot approve the application in its present form.”

“The FDA determined that the effect of bone-metastasis-free survival was of insufficient magnitude to outweigh the risks (including jaw osteonecrosis) in the intended population,” according to an Amgen press release.

The agency requested data from clinical trials demonstrating a favorable risk/benefit profile that is generalizable to the American population, the company stated, adding that “we will work with the FDA to determine any next steps.” Source

In conclusion, following the disapproval of Denosumab by the FDA Oncologic Drugs Advisory Committee, the manufacturer is advised to go back to the lab for more researches. Its desire to work with the FDA in determining what next step to take is a right disposition to assume. The FDA helps to protect the interest of all when it comes to approvals, and with its wealth of experience in laboratory testing, the interest of patients are protected. Denosumab has been approved in the US and Europe for bone metastases related conditions, its efficacy as a metastatic prostate cancer drug is stalled for now by the FDA.

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