The FDA is conducting an industrywide evaluation of drugs with indications given accelerated approval in an effort to determine whether confirmatory clinical trials verified the therapies’ clinical benefits. Manufacturers already have withdrawn indications approved in the U.S. for four drugs, and an upcoming meeting will scrutinize six additional indications. It’s important that the agency speed approvals of cancer drug indications if they look promising, contend experts, but it’s equally important that the FDA confirms their efficacy.
“The FDA has a large toolbox of options for getting important products to the market,” says Nancy Dreyer, Ph.D., chief scientific officer at IQVIA Real World Solutions. These include priority review, accelerated approval, fast track and breakthrough therapy designations, as well as emergency use authorizations (EUAs), which are used in emergency situations, such as the COVID-19 pandemic. “It appears that we are well covered in terms of having EUA for emergencies and other fast-track options that assure that the risks are not likely to outweigh the benefits of a new treatment and that the new treatment offers meaningful therapeutic benefit.”