Top officials aim to reshape the FDA to prepare for 'avalanche' of cancer products

Forbes

30 June 2016 - For 20 years, Richard Pazdur has run the office of the FDA charged with evaluating new cancer drugs, guiding the pharmaceutical industry as the business of oncology went from a relative backwater to the main event.

Yesterday, as part of the $1 billion National Cancer Moonshot effort being run by Vice President Joseph Biden, Pazdur was elevated to a new role: running a new Oncology Center of Excellence that will coordinate all of the FDA’s clinical efforts in cancer.

Cancer medicines now account for 40% of the drugs under development, but the current revolution–that’s the word most doctors use–going on in cancer care doesn’t just involve drugs. Previously, Pazdur had authority over the pills and antibodies developed by companies like Roche, Merck and Bristol-Myers Squibb BMY +0.31%. But diagnostic tests, from firms like Illumina ILMN +0.46% and Foundation Medicine, are likely to be just as important. And now companies like Novartis, Juno Therapeutics and Kite Pharmaceuticals are developing genetically engineered cells that hunt down and kill cancer–products that would be reviewed by yet another FDA division.

“We want to have some uniformity in how we unite these products,” says Pazdur, who will serve as acting director of the center. “They’re being used together.”

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Michael Wonder

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Michael Wonder