A Closer Look
The FDA's accelerated approval program aims to provide early access to promising cancer drugs. However, a new study reveals that many of these drugs fail to demonstrate long-term benefits.
Researchers analyzed 46 cancer drugs granted accelerated approval between 2013 and 2017. They found that only 43% of these drugs showed clinical benefit in confirmatory trials, even though 63% received full approval.
This raises concerns about patient understanding of accelerated approval and the potential for false hope. Dr. Edward Cliff, co-author of the study, emphasizes the importance of informing patients about the uncertainty surrounding these drugs.
Dr. Jennifer Litton, an oncologist not involved in the study, highlights the need for clear communication between doctors and patients. She stresses the importance of explaining the evidence, even if it involves less definitive measures like tumor shrinkage or stability.
The study also acknowledges recent updates to the accelerated approval program, granting the FDA more authority to withdraw drugs that fail to meet expectations. This aims to ensure that patients have access to effective treatments and avoid unnecessary exposure to ineffective ones.
Overall, the study highlights the need for careful evaluation of accelerated approval drugs and transparent communication with patients about their potential benefits and limitations.