Breakthrough Therapy designation is a United States
Food and Drug Administration expedited drug development tool, which allows the FDA under Section 902 of the July 9, 2012
Food and Drug Administration Safety and Innovation Act, to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.
A breakthrough therapy designation can be assigned to a drug if "it as a drug which is intended alone or in
combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the
preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development