(NEWSnet/AP) — U.S. Food and Drug Administration’s accelerated approval program is intended to give patients early access to promising drugs. But how often do these drugs improve or extend a patient’s life?

In a new study, researchers found most cancer drugs of that type do not demonstrate such benefits within five years. 

From 2013-2017, 46 cancer drugs were  ranted accelerated approval. Of those, 63% were converted to regular approval, even though only 43% demonstrated a clinical benefit in confirmatory trials.

The research was published in Journal of the American Medical Association and discussed Sunday at the annual meeting of American Association for Cancer Research.

“Five years after the initial accelerated approval, you should have a definitive answer,” said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.”

The program was created in 1992 to increase access to HIV drugs. Today, 85% of accelerated approvals go to drugs that fight cancer.

It allows FDA to grant early approval to medicine that shows promising initial results for treating debilitating or fatal disease. In exchange, drug companies are expected to conduct rigorous testing and produce evidence prior to receiving approval.

Follow NEWSnet on Facebook and X platform to get our headlines in your social feeds.

Copyright 2024 NEWSnet and The Associated Press. All rights reserved.