Study: Many cancer drugs unproven 5 years after accelerated approval
Time:2024-04-30 14:03:58 Source:styleViews(143)
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.
Previous:Revealed: Billy Vunipola was TEETOTAL for almost two years
Next:Rubiales denies wrongdoing when questioned in probe into Saudi Arabia deal for Spanish Super Cup
You may also like
- Thai FM offers to resign after cabinet reshuffle
- Spirit down Dash 3
- What we're watching: The Great
- US regulator grounds Boeing MAX 9 indefinitely, flights cancelled
- This summer, John Krasinski makes one for the kids with the imaginary friend fantasy ‘IF’
- Biden: US will defend Philippines if vessels are attacked — Radio Free Asia
- Robert Kennedy Jr apologises to family over Super Bowl ad
- Ukraine aid worker Chris Parry died unlawfully alongside Andrew Bagshaw, inquest hears
- United Methodists prepare for votes on lifting LGBTQ bans and other issues at General Conference