Breakthrough can lead to Accelerated Approval
From 2012 through 2017, the FDA approved 46 therapeutics with Breakthrough Therapy designation on the basis of 89 pivotal trials. The most common therapeutic areas were cancer (n = 25; 54.3%) and infectious disease (n = 8; 17.4%) and 54.3% (n = 25) were considered first-in-class.
Therapeutics were also commonly designated as orphan products (n = 30; 65.2%) and qualified for Fast Track review (n = 24; 52.2%) and Accelerated Approval (n = 18; 39.1%); all were granted Priority Review (n = 46; 100%) (Table 1).