Medscape July 23, 2024
Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration (FDA) pathway allows promising new cancer agents to reach the market, and patients, sooner.
But speed can come at a price.
The bargain the FDA has struck with manufacturers is companies can use less robust metrics — surrogate markers — to get their drugs to market earlier. These markers, which typically track how well a drug shrinks a tumor or halts tumor growth, act as a temporary stand-in for the ultimate goals — better overall survival and quality of life.
In exchange, manufacturers agree to run confirmatory trials following an FDA approval to determine whether the new drug or regimen does indeed reach...
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