FDA Pathway · Base-Rate Reference
Breakthrough Therapy FDA Base Rates
Historical first-cycle approval rates, typical time-to-decision, and AdCom frequency for Breakthrough Therapy submissions across 9 therapeutic-area indications. Approximate base rates for framing, not prediction.
What is Breakthrough Therapy?
FDA designation with intensive guidance + rolling review for drugs showing substantial improvement over available therapy.
Breakthrough Therapy base rates by indication
| Indication | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| Oncology | 88% | n~180 | priority 6 months | rarely | Breakthrough designation correlates strongly with first-cycle approval; high single-arm study acceptance. |
| Rare Disease / Orphan | 85% | n~80 | priority 6 months | sometimes | Breakthrough + orphan combination drives among the highest approval rates. |
| Immunology | 85% | n~25 | priority 6 months | rarely | Usually approved first cycle with expedited label negotiations. |
| Infectious Disease | 85% | n~30 | priority 6 months | rarely | HIV and HCV breakthrough programs historically approved first cycle. |
| Other | 82% | n~60 | priority 6 months | rarely | Breakthrough designation is among the strongest predictors of approval. |
| Endocrinology/Metabolic | 80% | n~15 | priority 6 months | sometimes | Rare metabolic and novel mechanism programs; strong first-cycle record. |
| Cardiovascular | 75% | n~15 | priority 6 months | sometimes | Breakthrough rare in CV; when granted, usually leads to first-cycle approval. |
| Neurology | 70% | n~20 | priority 6 months | usually | Breakthrough accelerates timelines but does not eliminate evidence debates. |
| Psychiatry | 70% | n~10 | priority 6 months | usually | Used for postpartum depression, TRD psychedelics, and similar; REMS common. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Cross-check against recent CDER/CBER reports for specific assets.
Run your specific pathway + indication combo
The full calculator lets you layer on designations (Breakthrough, Fast Track, Priority Review) and see how they shift base rate, time-to-decision, and AdCom likelihood.
Open the calculator →Who has upcoming Breakthrough Therapy dates?
Our live PDUFA calendar tracks upcoming FDA action dates across all Breakthrough Therapy and related submissions with sponsor, ticker, drug, and catalyst context.
View 2026 PDUFA calendar →Related pathways
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