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Sep 6, 2012

U.S. Outpaces Europe in Cancer Drug Approvals

  • Cancer drugs found approvals easier to obtain over the past decade in the U.S. than in the European Union, where nononcology treatments took less time to clear reviews, according to a study by the Tufts Center for the Study of Drug Development (CSDD).

    From 2002 through 2011, Tufts said approval timeframes for cancer drugs were 10 months shorter than those of nononcology medicines within the E.U. But in Europe, reviews for noncancer drugs are two months shorter than those for cancer treatments.

    One possible reason for the disparity: oncology approvals accounted for 19% of all new drug approvals in the U.S., but just 12% in the E.U.

    In turn, the reason for that difference could be another finding in the Tufts study: Between 2007 and 2011, 39% of U.S. orphan drug approvals were for oncology medicines, up from 31% in 2002–06. However, 37% of European orphan drug approvals were for oncology medicines in 2007–11, up from 28% between 2002 and 2006.

    Tufts’ announcement of the study did not specify what the timeframes were for cancer vs. noncancer drug reviews. Tufts did release review timeframes for all drugs of 8 years in 2002–06 and 7.4 years in 2007–11. Those timeframes reflected total development and approval time for NME and new BLA oncology and nononcology approvals in the U.S.

    “What’s encouraging is that while total development time for oncology and nononcology 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,” Christopher-Paul Milne, D.V.M., director of research at Tufts CSDD, said in a statement.

    “Oncology drug development continues to be challenging due to smaller patient populations for recruitment and longer periods for evaluation of treatment response,” Dr. Milne added.

    The Tufts study also found that in both the U.S. and Europe, there was little difference in approval times between products that had a special designation—such as fast track, accelerated approval, and orphan designation—and those that did not.

    Total development and approval time in the U.S. for fast track drugs dropped by 20%—from 8.3 years in 2002–06 to 6.6 years in 2007–11, according to the study.

    Study results were reported in the September/October Tufts CSDD Impact Report (subscription required).


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