Study: Many cancer drugs unproven 5 years after accelerated approval
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
Shocking moment Pennsylvania man pulls a gun on pastor in front of horrified congregation
A church service in Pennsylvania nearly took a fatal turn this week when a man pulled a gun on a pas2024-05-07The black market dealers delivering Elon Musk's Starlink to US adversaries
A shadow network of black market dealers, some in the United Arab Emirates, has been selling SpaceX2024-05-07Spotify hikes its prices for millions of UK customers: Premium plans jump by up to 13%
With more than 600 million users worldwide, Spotify is one of the biggest apps of them all. But its2024-05-07Airplane passenger sparks furious debate about PETS flying in
An airplane passenger has sparked a furious debate about whether pets should be allowed to fly in-ca2024-05-07Former cruise ship worker reveals the six things she would NEVER do on board
A former cruise ship employee has revealed the six things she would never do on board - but how many2024-05-07Children addicted to tech including smartphones are more at risk of psychosis, study suggests
Children addicted to smartphones, iPads and video games are more likely to suffer psychotic episodes2024-05-07
atest comment