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Oncology Drugs Get Faster Approvals in U.S.

Article

While approval times for new oncology drugs are getting shorter in the U.S., the opposite is true over in the European Union, where non-oncology drugs are seeing shorter approval times.

In the U.S., approval times for new oncology drugs are getting shorter, according to a study by the Tufts Center for the Study of Drug Development (CSDD)

During the last decade it too less time for an oncology drug to get approved than for a non-oncology products. That holds true in the U.S., at least. Meanwhile in the European Union (EU) the opposite was true.

Approval times in the U.S. for oncology drugs were 10 months shorter when compared to non-oncology drugs. However, in Europe, non-oncology drugs usually had an approval time two months shorter than oncology drugs. That time difference has translated to oncology drug approvals accounting for 19% of all new drug approvals in the U.S. from 2002 to 2011 and only 12% in the EU.

"Oncology drug development continues to be challenging due to smaller patient populations for recruitment and longer periods for evaluation of treatment response," Christopher-Paul Milne, director of research at Tufts CSDD, said in a statement.

There was little different in approval times between products with special designations — such as fast track — and those without. Total development and approval time in the U.S. for fast track drugs dropped b 20%. In 2002 to 2006 the total time was 8.3 years, but from 2007 to 2011 the total time was only 6.6 years.

"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," added Milne.

A Health Affairs study from June 2011 came to similar conclusions while looking at cancer drugs approved by the Food and Drug Administration and the European Medicines Agency from 2003 to 2010. That study found that with only three drugs did European regulators act faster than the FDA.

According to the study, the median time for approval in the U.S. was just six months.

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