Study: The FDA's 'breakthrough' program is speeding up cancer approvals

Print 17 March 2016
Damian Garde / Fierce Biotech

Since the FDA unveiled its breakthrough therapy designation in 2012, cancer drugs brought into the program won approval roughly three months faster than other oncology therapies, according to a new study.

Nonprofit group Friends of Cancer Research pored over stats from the 29 cancer drugs approved from January 2013 to December 2015. Of the 41% of those therapies that won breakthrough tags at some point in their development, the median approval time was 2.9 months before the FDA's promised decision date, according to the study. Non-breakthrough drugs charted a .2-month lead time.

Zooming out to look at total development time, the breakthrough tag looks even more valuable. The time from Phase I enrollment to final approval was roughly 2.2 years shorter at median for breakthrough cancer drugs versus the field, the study found. Eight of the 12 approved drugs with breakthrough status--66%--won over regulators based on Phase I or Phase II data, according to the study, while just 24% of the rest got to market without late-stage trials.

The FDA launched its breakthrough program as a means to accelerate the development of treatments for unmet medical need, paying particular attention to oncology. The effort has so far been a success, Friends of Cancer Research concludes, but the group cautions that it's too early to make a final determination on the program.

The perceived success of the FDA's program has led to similar efforts around the world, including Japan's sakigake effort and the European Medicines Agency's recently launched Priority Medicines initiative.

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