Table 3.

Drug Approval Times in Years in FDA Accelerated Pathways

Track Designation∗	Major Cancer	Minor Cancer	Decrease in Review Time
Fast Track	7.2	9.2	2.0
Breakthrough Therapy	6.4	9.6	3.2
Accelerated Approval	6.2	9.6	3.4
Priority Review	8.0	10.2	2.2

Average times in years from Investigational New Drug application to U.S. Food and Drug Administration (FDA) drug approval for anticancer drugs and biologicals achieving accelerated track designation at the FDA from 2012 to 2017 compared with overall anticancer drug approval times for the same period (median of 8.3 ys, n = 115 drugs), and separated by categorization as a drug for “minor” versus “major” cancer. (24).

^∗Regenerative Medicine Advanced Therapy designation was created too recently to comment on review times.