publication date: Oct. 13, 2017
Conversation with the Cancer Letter
Rubin: FDA helped Merck figure out how to channel science into regulatory approval
Global Clinical Oncology, Merck Research Laboratories
The idea that led to the site-agnostic indication for Keytruda (pembrolizumab) came from the academic oncologists, who ended up defining the biologic mechanism of activity of this class of drugs.
When FDA got involved, it took an activist stance, coming up with regulatory ideas to match the elegance of science.
“When they saw these data, they were really helping us to figure out what exactly we would provide for them to be able to sign off on a tissue-agnostic approval, and so it really was a collaborative effort once the data started to come in, and once we had the breakthrough status from them,” said Eric Rubin, vice president, Global Clinical Oncology, Merck Research Laboratories. “I would say it really is a nice example of collaboration of academia, FDA, and industry.”
Rubin spoke with Paul Goldberg, editor and publisher of The Cancer Letter.
I believe that in December 2012, the Hopkins folks came to you and asked for the drug, and you gave them the drug. What was the decision like on Merck’s side, whether to give a drug?
This was before Keytruda had been approved. I would say, … Continue reading Rubin: FDA helped Merck figure out how to channel science into regulatory approval
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