FDA Breakthrough Designations Lead to Priority Reviews, Report Finds
Drugs given the FDA's breakthrough therapy designation are frequently granted priority review, a status that accelerates the regulatory assessment of promising medicines targeting serious or life-threatening conditions814.
A recent analysis of 599 breakthrough therapy designations (BTDs) from 2013 through 2025 found that approximately 72% of these drugs ultimately received FDA approval, with an additional 13% still under review10.
Cancer therapies represent the largest proportion of BTDs (46%), followed by drugs for infectious, metabolic, and neurological diseases10.
Therapies for rare diseases accounted for the majority of all breakthrough therapy designations between 2013 and 2025, indicating the FDA's emphasis on unmet medical needs10.
In 2024, 56% of all novel drug approvals (28 of 50) were designated for priority review, underscoring the connection between special review pathways and faster market access11.
The breakthrough therapy designation is only one of several FDA programs—including priority review, accelerated approval, and recent pilots like the Commissioner's National Priority Voucher (CNPV)—intended to expedite drug development and review for transformative therapies27810.
Priority review reduces FDA evaluation time from the standard 10–12 months down to 6 months for most applications, and certain new pilot programs are attempting to shorten this even further for especially impactful therapies46.
The increase in review designations since 2012, including the introduction of BTDs, reflects the FDA's evolving approach to foster biotechnological innovation and address urgent public health needs12.
Sources:
2. https://pubmed.ncbi.nlm.nih.gov/37962724/
4. https://www.dcatvci.org/features/fda-begins-pilot-for-speeding-drug-reviews-with-a-priority-for-reshoring-mfg/
6. https://www.fiercebiotech.com/biotech/fda-opens-national-priority-fast-track-offering-2-month-reviews-onshoring-and-affordability
7. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
8. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
10. https://www.biospace.com/fda/nearly-three-quarters-of-fda-breakthrough-designated-drugs-win-approval-report
11. https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf
12. https://www.pharmaceutical-technology.com/analyst-comment/fda-review-designations-innovation/
14. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy