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

30 Jan 2024

Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project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.

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...