Accelerated approval can be useful. However, some cancer drugs that underwent the FDA's accelerated approvals showed no clinical benefits.
Fast-Tracked Cancer Drugs Show No Clinical Benefits
A new study has found that in follow-up trials conducted after more than five years, around 40% of anti-cancer treatments approved under the US Food and Drug Administration's (FDA) expedited approvals pathway between 2013 and 2017 failed to demonstrate a therapeutic benefit.
The FDA's expedited approvals process granted provisional clearance to 59 cancer medications over 129 indications or uses between 2013 and 2023.
By the middle of 2023, seven medications out of the 46 medicinal indications approved between 2013 and 2017 still awaited the findings of confirmatory trials. Ten medications had been pulled in the interim.
However, the researchers discovered that 41% of the 46 cancer medications given expedited approval during that time, or 19 of them, did not prolong patients' lives or enhance their quality of life.
When you include the seven current trials with pending results, that percentage jumps to 57% of cancer medications that were given fast track fail to demonstrate efficacy five years after approval.
"Although accelerated approval can be useful, some cancer drugs do not demonstrate benefit in extending patients' lives or improving their quality of life," epidemiologist Ian Liu and colleagues wrote in the paper.
However, the system is improving. Fast-tracked medications that were shown to be useless in follow-up trials were removed from the approvals process more quickly in 2017-in only 3.6 years-as opposed to roughly ten years in 2013.
What Is the FDA's Accelerated Program?
The FDA launched the Accelerated Approval Program to expedite the approval of medications for the treatment of severe illnesses and address unmet medical needs by using a surrogate endpoint. A surrogate endpoint is a marker that is thought to predict clinical benefit but is not a measure of clinical benefit itself.
Physical signs, radiographic images, laboratory measurements, and other measures are examples of such markers. Using a surrogate endpoint can significantly reduce the time needed to obtain FDA approval.
Pharmaceutical companies still need to research to verify the expected clinical benefit. Traditional FDA approval is given to the drug if the confirmatory trial demonstrates that the medication genuinely offers a therapeutic benefit.
The FDA has regulatory procedures that could take the drug off the market if the confirmatory trial fails to demonstrate that the medication has clinical benefit.
Since 1992, the US FDA's rapid approvals program -- which was established in response to the HIV/AIDS crisis of the 1980s and early 1990s-- has made it possible to approve medications that treat serious illnesses and meet unmet medical needs at an early stage of development.
The FDA frequently grants expedited authorization, particularly for cancer treatments. The rapid approvals process is used for one-third of all oncology drug approvals, and cancer medicines account for more than 80% of all accelerated approvals.
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