A new study has found that around 40 percent of anti-cancer therapies fast-tracked through the US FDA's accelerated approvals pathway between 2013 and 2017 didn't show clinical benefit in follow-up trials more than five years on.
drugs that are fast-tracked through approvals don't always work as hoped. A new study has found around 40 percent of anti-cancer therapies ushered through the US Food and Drug Administration's accelerated approvals pathway between 2013 and 2017 didn't show clinical benefit in follow-up trials more than five years on.program has, since 1992, allowed for the early approval of drugs that treat serious conditions, and fill an unmet medical need.
Among the 46 drug indications approved between 2013 and 2017, results of confirmatory trials were still outstanding for seven medicines by mid-2023. Meanwhile, 10 drugs had been withdrawn. Add in the seven ongoing trials for which results aren't yet available, and that figure rises to 57 percent of fast-tracked cancer drugs failing to show benefit five years post-approval.
Except pharmaceutical companies are taking longer to demonstrate that drugs are effective in mandatory post-approval studies, meaning those drugs are available for years before clinicians – and their patients – can be sure 'stand-in' surrogate markers actually reflect clinical benefit.
Drugs Fast-Tracked Approvals Anti-Cancer Therapies FDA Clinical Benefit Follow-Up Trials
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