“PHILADELPHIA – Within six months of the U.S. Food and Drug Administration’s (FDA) move to restrict the label of two immunotherapies, usage of those therapies among oncologists dropped by about 50 percent, according to a new study from researchers in the Abramson Cancer Center at the University of Pennsylvania. The findings come as the world of cancer medicine grapples with the rapid pace of approval for new therapies, particularly as it relates to the FDA’s accelerated approval (AA) program. Researchers say these findings offer reassurance that oncologists can be nimble enough to quickly incorporate the latest guidelines into their practices when new safety data comes to light. JAMA published the results today.
The FDA’s AA program has come under significant scrutiny in recent months. Supporters say it can bring promising drugs into the clinic more quickly, which can benefit millions of patients. Critics say these drugs should not come to market before undergoing randomized phase III clinical trials, which is considered the gold standard in medical and drug development research.”