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Pazdur On Accelerated Approval: FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail

 
• By Sue Sutter

Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project Confirm lead Gautam Mehta spoke with the Pink Sheet about dangling indications, FDORA reforms and the withdrawal process.

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A nuanced approach, rather than a knee-jerk reaction, is needed in deciding whether to pull an accelerated approval drug with a failed confirmatory trial. • Source: Shutterstock

Oncology Center of Excellence Director Richard Pazdur believes the US Food and Drug Administration needs to do a better job explaining to the public why it might not automatically seek withdrawal of an accelerated approval drug when a confirmatory trial fails.

When an anti-cancer drug has demonstrated biological activity through response rate data, the agency needs to take a nuanced, rather than knee-jerk, approach to deciding whether it should come off...

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