Oncology drugs get faster approvals than non-cancer drugs in USA, but opposite case in Europe, Tufts research finds

Approval times for new oncology drugs in the USA during the last decade were shorter than those for non-oncology products, while the reverse was the case in the European Union, according to a study recently completed by the Tufts Center for the Study of Drug Development.

For drugs approved by the US Food and Drug Administration from 2002 through 2011, approval times were 10 months shorter for oncology versus non-cancer drugs. In contrast, in Europe, approval times were almost two months shorter for non-oncology versus cancer drugs. During that period, oncology approvals accounted for 19% of all new drug approvals in the USA and 12% in the EU.

In addition, in both regions 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.