On Friday, Richard Pazdur, the director of the FDA Oncology Center of Excellence, sat down with STAT for a frank conversation at an event at the annual meeting of the American Society of Clinical Oncology.
What topics did he cover? What he tells companies when they need to pull their drugs, for one thing: “If you don’t feel the light, you’ll feel the heat.” Pazdur said he wouldn’t comment directly on accelerated approval of the controversial Alzheimer’s drug, Aduhelm, but did say that he thinks such approvals, based on new endpoints, need to involve more public discussion. In the wake of the Aduhelm approval, Pazdur has made public statements to defend the accelerated approval process.
He also made two statements that will be closely watched by the drug industry. He would like to push cancer drug developers to move from studies without control groups to randomized trials that factor in early looks at the data in order to get faster approvals.
Create a display name to comment
This name will appear with your comment