publication date: Sep. 16, 2016

ODAC Slams Spectrum for Massaging Data From Two Bladder Cancer Trials

By Paul Goldberg

A brief consult with an undergraduate earning a B or above in Statistics 101 might have acquainted Spectrum Pharmaceuticals executives with all the science that would have saved them from a devastating encounter with an FDA advisory committee.

Yet, there they were, black suits and all, at a suburban Maryland conference center, watching the Oncologic Drugs Advisory Committee vote unanimously against approval of Spectrum’s bladder cancer therapy Qapzola (apaziquone). 

During the Sept. 14 meeting, FDA officials said repeatedly that taking apaziquone, a drug chemically related to mitomycin, to ODAC wasn’t their idea.

After two registration trials failed to show superiority to placebo, the agency advised Spectrum to withdraw the New Drug Application. The company was told that its other alternative would be to try to convince ODAC.

The company’s extensive massaging of data—pooling data from the negative trials and conducting post hoc analyses to find activity—didn’t win over ODAC member Bernard Cole, professor of mathematics and statistics at the University of Vermont, and the other 13 members of the committee that advises the agency on clinical issues.

“This is what I tell my students, how not to do things: if you get a result, do an analysis, get a result, and you don’t like it, you add data, and you keep doing that, and eventually you get the result that you want,” said Cole, professor of mathematics and statistics at the University of Vermont. “So we have to be really careful when we add data to a study and then reanalyze.”

Spectrum was seeking approval for immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.

The ODAC … Continue reading 42-34 ODAC Slams Spectrum for Massaging Data From Two Bladder Cancer Trials

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