The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives?
In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years.
“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 speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs.
It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval.
Related articles:
Related suggestion:
Ravens pick Clemson CB Nate Wiggins in the first round, adding depth and speed to their secondaryFormer coal CEO Don Blankenship is trying to win a U.S. Senate seat, this time as a DemocratColts take first defensive player of NFL draft, UCLA edge rusher Laiatu Latu at No. 15House approves bill to criminalize organ retention without permissionThe collapse of the SNPPackers take Arizona offensive tackle Jordan Morgan with 25th overall pick in NFL draftFrustrated with Brazil's Lula, Indigenous peoples march to demand land recognitionChina to launch ShenzhouBuccaneers add offensive line help, select Duke C Graham Barton in NFL draftColumbia University extends negotiations with student protesters
2.3015s , 6499.09375 kb
Copyright © 2024 Powered by Study: Many cancer drugs unproven 5 years after accelerated approval ,Culture Channel news portal