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Dr Howard Burris Discusses Simultaneous Approvals of Novel Therapies, Diagnostics

With a biomarker attached, the odds of a drug being approved goes up from about 10% to greater than 25%, explained Howard A. "Skip" Burris, III, MD, FACP, FASCO, president, clinical operations, and chief medical officer of Sarah Cannon Research Institute.


With a biomarker attached, the odds of a drug being approved goes up from about 10% to greater than 25%, explained Howard A. "Skip" Burris, III, MD, FACP, FASCO, president, clinical operations, and chief medical officer of Sarah Cannon Research Institute.

Transcript

When the FDA approved atezolizumab for the treatment of triple-negative breast cancer, it also approved the VENTANA PD-L1 assay. Do you think simultaneous approvals like this will be a trend in the future?

I do think that we’re going to see more and more of the development of the biomarker along with the individual cancer therapy. There’s some data that’s been published recently that has been talked about that shows that if a biomarker is part of your clinical development strategy, you have a much greater chance of approval. We know that many drugs come out of the phase 1 setting and don’t make it through the whole approval process, but with a biomarker attached, the odds of that drug being approved go up from about 10% to greater than 25%. So, identifying the patients that are most likely to benefit, I think, will be key, and it’s nice to see the FDA working with pharma to in fact promote this kind of strategy.

 
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