September 5, 2012
Oncology Drugs Get Faster Approvals than Non-Oncology Drugs in U.S., But the Opposite is True in the EU
BOSTON — Sept. 5, 2012 — Approval times for new oncology drugs in the United States during the last decade were shorter than approval times 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 U.S. Food and Drug Administration from 2002 through 2011, approval times were 10 months shorter for oncology vs. non-oncology drugs. In contrast, in Europe, approval times were almost two months shorter for non-oncology vs. oncology drugs.
During that period, oncology approvals accounted for 19% of all new drug approvals in the U.S. 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.
"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