Many Accelerated Approval Cancer Meds Don’t Live Up to Their Promise, Says Study

Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on the market for years until postmarketing studies show their true clinical impact, a new analysis has shown.

The findings argue for pivotal trials that focus on meaningful patient endpoints, Aaron S. Kesselheim and colleagues wrote in JAMA Network.

The FDA rarely requests withdrawal of indications that have received regular approval but has requested withdrawal of 27 cancer drug indications approved via accelerated approval, the authors wrote.

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