publication date: Nov. 20, 2015

CBER’s All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Drug 


One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.

By that stage in the game, advisors would be asked to discuss the outcomes, as opposed to the biological mechanisms for achieving them.

This was even before the agency’s reorganization of its oncology units more than a decade ago. In those days, small-molecule compounds went to one bureaucratic unit of the FDA Center for Drugs Evaluation and Research—while biologics, including monoclonal antibodies and growth factors, went to the Center for Biologics Evaluation and Research.

Nonetheless, small-molecule drugs and biologics both went to the same advisory group: the Oncologic Drugs Advisory Committee, which offered clinical guidance.

After the reorganization, cellular, tissue and gene therapies for cancer remained in the FDA Center for Biologics Evaluation and Research, and, as the Nov. 18 meeting of the advisory committee summoned by that unit of FDA illustrated, things at CBER are done differently.

First, it’s unlikely that the therapy in question, a biologic immunotherapy for bladder cancer sponsored by Telesta Therapeutics Inc., would have made it to an advisory committee at CDER—certainly not in that form.

The company’s single-arm trial missed its primary endpoint and was stopped prematurely. Worse, it was unclear what kind of patients benefited and what the characteristics of their … Continue reading 41-43 CBER’s All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Drug

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