Over the last decade, the times taken by US regulators to approve new drugs used in the treatment of cancer have been shorter than the times for non-oncology products, while in the European Union (EU) the reverse has been the case, according to new research.
For new drugs passed by the US Food and Drug Administration (FDA) from 2002 to 2011, the time taken to approve them was, on average, 10 months shorter for oncology treatments than for drugs to treat all other conditions, according to the study, which is published by the US Tufts Center for the Study of Drug Development (CSDD).In contrast, approval times in the EU were almost two months shorter for non-oncology drugs than those for oncology treatments, it adds.
The researchers also found that, in both regions, there was little difference in approval times between new treatments that had been given a special designation - such as fast track, accelerated approval or orphan designation - and those that had not.
"Oncology drug development continues to be challenging, due to smaller patient populations for recruitment and longer periods for evaluation of treatment response," commented Christopher 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," he added.
The new study, which is reported in the September/October Tufts CSDD Impact Report, also shows that, during the 2002-2011 review period:
- approval times for non-oncology drugs in the EU were 27% shorter than similar approvals in the US, but 54% longer for oncology therapeutics;
- the total development and approval time in the US for drugs given fast-track designation dropped 20%, from 8.3 years in 2002-06 to 6.6 years in 2007-11; and
- during 2007-11, 39% of US approvals for orphan drugs were for oncology products, an increase of 31% compared to 2002-06, while in the EU 37% of the orphan drugs approved were for the treatment of cancer, which is a rise of 28% over 2002-06.