The pharmaceutical industry has brought a “staggering” number of new cancer drugs onto the market recently, and the FDA’s incoming acting chief wants to continue setting new records.
“Industry is investing more and more heavily in cancer research. I believe this trend reflects our improved basic biological understanding of cancer,” said Norman E. “Ned” Sharpless, who is currently director of the National Cancer Institute, part of the National Institutes of Health.
The FDA granted 48 new approvals in oncology last year, including Pfizer’s Vizimpro and Astellas Pharma’s Xospata, compared to just two approvals in all of 2005. “It depicts an impressive—I might say staggering—number of new cancer drugs that were approved in 2018,” he said. “To my new colleagues at FDA, I expect us to keep this up when I get over there.”
From NCI to FDA
Sharpless’s speech at the American Association for Cancer Research annual meeting in Atlanta marks what likely will be his final public appearance as the NCI director before he becomes acting commissioner of the Food and Drug Administration. The current commissioner, Scott Gottlieb, expects April 5 to be his last day.
“I am excited about the opportunity to work at the FDA, the world’s most important guardian of the public health,” Sharpless said.
With a more than $6 billion budget, the NCI is the largest of the NIH’s 27 institutes and centers. Sharpless joined the agency in October 2017 after running the University of North Carolina at Chapel Hill’s comprehensive cancer center.
Modernizing the clinical trial system to allow more oncology patients to participate and align more closely with targeted treatments based on a better understanding of the genomic underpinnings of cancer has been one of Sharpless’s priorities over the past year and a half. The NCI has increased funding by more than $30 million per year, for clinical trials networks and contracts it funds, he said.
“Clinical trials are expensive, but they are worth the investment,” he said.
Earlier in his speech, he noted many of the current successes bringing new cancer treatments to market are due to millions of patients who participated in clinical trials with the full knowledge that they personally would never benefit from any new discovery.
“In their worst days, they built a fire for others to warm their hands,” Sharpless said. “Our progress is their legacy. It is our charge to continue this progress for those who come after us.”
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