Study: Cancer drugs may stay approved despite proof of inefficacy

Many cancer drugs that gain accelerated approval in the U.S. often stay approved despite later studies showing no real survival benefits, according to a new study featured in JAMA Internal Medicine.

For the study, researchers analyzed 31 clinical trials done on 18 different cancer treatments approved by the Food and Drug Administration between 2008 and 2012. Researchers estimated the drugs ranged in price from $20,000 to $170,000.

Of the 13 drugs with publicly available efficacy data, none were proven to prolong life and only one treatment provided enough evidence to say it improved quality of life. Only one of the drugs in the study — Genentech's breast cancer drug Avastin — lost its approval status.

"We were shocked to find that these drugs don't save lives and don't improve quality of lives," lead author Diana Zuckerman, PhD, president of the National Center for Health Research and the Cancer Prevention and Treatment Fund in Washington, D.C., said in a Reuters report.

The FDA told Reuters the agency takes into account that people with resistant cancers have few or no therapeutic options when examining the risks and benefits of these cancer drugs.

"It has been widely accepted that benefit can be demonstrated by a number of endpoints, not just overall survival," the FDA said in the statement, according to the report.

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