The FDA began implementing the breakthrough therapy designation in 2012, following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA). Through the program, a new drug may be designated as a breakthrough therapy by the Food and Drug Administration (FDA) if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence suggests it provides a substantial improvement over existing therapies.  After more than 3 years of implementation, the program has upwards of 300 requests, with FDA granting more than 100 designations, and approving more than 30 Breakthrough Therapy designated treatments. 

In the study below, published in Nature Reviews Drug Discovery, Friends reports on the trends of the breakthrough therapy designation in oncology.