One-third of the uses for cancer drugs granted speedy approvals remained on product labeling even after follow-up studies failed to confirm their benefits, according to a new analysis in BMJ. And at the same time, widely-read guidelines for physicians also continued to recommend these treatments.
At issue is the accelerated approval program created nearly three decades ago to hasten availability of drugs for serious conditions with unmet medical needs. However, since the program allows regulators to rely on surrogate measures that are likely to prove effectiveness in exchange for access, drug makers must run trials to later verify the medicines are benefiting patients as intended.
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