Tufts: Cancer drugs win a speedier race to the FDA goal line

Anyone trying to explain the onrush of new cancer therapies in the pipeline should check out a new report from the Tufts Center for the Study of Drug Development, which found that cancer drugs have enjoyed faster approval times at the FDA than all other disease categories combined. And the center concluded that cancer drugs claimed a growing share of the orphan drug market as the total time it requires to take a fast-track drug through development to an approval shrunk by an impressive 1.7 years over the past decade.

The number crunchers at Tufts took a look at the figures on development and approvals from 2002 through 2011. During that time, cancer drugs enjoyed approval times that were 10 months shorter than non-oncology drugs in the U.S., while in Europe cancer drugs required an added two months on approval times. Tufts also found that:

  • The combined development and approval time in the U.S. for fast track drugs shrunk by 20%--down from 8.3 years in the 2002-06 time frame to 6.6 years in 2007-11. But total development and approval times for all drugs were shorter, down from 8 years on average to 7.4 years, leaving little overall difference between the time required for all drugs compared to treatments with a special designation, such as accelerated review.
  • In the last four years, "39% of U.S. orphan approvals were for oncology drugs, up from 31% in 2002-06, while 37% of European orphan approvals were for oncology drugs in 2007-11, up from 28% in 2002-06."

"Oncology drug development continues to be challenging due to smaller patient populations for recruitment and longer periods for evaluation of treatment response," said Christopher-Paul Milne, director of research at Tufts CSDD. "What's encouraging is that while total development time for oncology and non-oncology drugs decreased by half a year during the 2002-11 period, for oncology drugs this was accomplished by process improvements that shortened regulatory review time."

During the last decade Tufts concluded that about one in 5 new drugs were for cancer. 

- here's the press release

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