Abstract
An analysis of drug approval times over the past decade shows that oncologic agents make it to market faster in the United States than non-oncologic drugs—and faster than cancer medicines in the European Union.
Over the past decade, the U.S. Food and Drug Administration (FDA) has given the green light to oncologic drugs more quickly than to non-oncologic drugs, but the reverse is true in Europe, according to a recent study from the Tufts Center for the Study of Drug Development (CSDD) at Tufts University in Boston, MA.
From 2002 through 2011, FDA regulators approved therapeutic agents for cancer 10 months faster than drugs for other conditions. In comparison, the European Medicines Agency (EMA) took almost 2 months longer to approve cancer drugs than non-oncologic medicines. Further distinguishing the agencies, the report noted that EMA approval times for oncologic therapeutics were 54% longer than the FDA's.
“Oncology drug development continues to be challenging,” says Christopher-Paul Milne, DVM, MPH, JD, director of research at Tufts CSDD, pointing to the difficulty in enrolling sufficient numbers of patients with specific genetic anomalies in clinical trials of targeted therapies and the longer period needed to evaluate a treatment response.
However, the Tufts analysis shows that the total time spent on clinical development and regulatory approval for oncologic drugs in the United States dropped by 6 months between 2002–2006 and 2007–2011, even though the amount of time spent on clinical development hardly changed between the 2 periods.
“This was accomplished by process improvements that shortened regulatory review time,” explains Milne. Therapies targeting rare and life-threatening cancers, as well as those for cancers with few approved treatments, can qualify for special designations that require speedier approval decisions. For example, average total development and approval time for fast-track drugs during the decade fell by 20%—from 8.3 years in 2002–2006 to 6.6 years in 2007–2011.
The statistics demonstrate that the FDA's efforts to streamline the approval process over the past decade are paying off. “The FDA has been dealing with that newer wave of cancer therapeutics for some time,” says Milne. “There's a certain efficiency that comes with that.”
