The US FDA allows some cancer drugs with accelerated approvals to remain on the market even if confirmatory trials fail, due to design issues rather than the drug itself being ineffective. Withdrawals are carefully considered, with factors such as lack of alternative treatments and absence of major toxicities or survival issues taken into account. Although this may lead to more drugs with marginal benefits on the market, it also provides more options for patients. The FDA continues to evaluate the balance between accelerated approvals and confirmatory trials to ensure the safety and efficacy of cancer drugs.
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Why a Failed Confirmatory Trial May Not Mean a Failed Drug
