# Breakthrough Therapy / Priority Review / Priority Voucher

Source: https://onco.cc/terms/breakthrough-designation/  
OnCo record `breakthrough-designation` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Breakthrough Therapy, Priority Review and the Priority Voucher are FDA fast lanes for drugs that look substantially better than existing options.

## Summary

Breakthrough Therapy, Priority Review and the Priority Voucher are the FDA's fast lanes for drugs that appear substantially better than existing options. Breakthrough Therapy, created in 2012, provides intensive regulatory guidance; Priority Review shortens the review clock to six months; and the Commissioner's National Priority Voucher pilot launched in 2025 promises reviews of one to two months for selected products, with Sacituzumab tirumotecan receiving one in July 2026. These pathways sit alongside Real-Time Oncology Review (RTOR), Fast Track and RMAT designations and Orphan drug designation under the FDA Oncology Center of Excellence. The term appears in the bottleneck on regulatory divergence and in an idea on transferable priority vouchers for first-in-class drugs.

## Fields

- Kind: Term
- Last checked: 2026-09-04

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Breakthrough_therapy
- Wikipedia: https://en.wikipedia.org/wiki/Breakthrough_therapy

## Connected records

- drugs: [Sacituzumab tirumotecan](https://onco.cc/drugs/sacituzumab-tirumotecan/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- ideas: [Transferable priority vouchers for first-in-class drugs, with price conditions](https://onco.cc/ideas/idea-fund-conditional-transferable-voucher/)
- terms: [BLA / NDA / MAA (marketing applications) and PDUFA dates](https://onco.cc/terms/bla-nda/), [China Drug Administration Law (2019) and expedited pathways](https://onco.cc/terms/china-drug-administration-law/), [Fast Track and RMAT designations](https://onco.cc/terms/fast-track-rmat/), [FDASIA 2012 and the origins of the expedited programmes](https://onco.cc/terms/fdasia-2012/), [ILAP (Innovative Licensing and Access Pathway)](https://onco.cc/terms/ilap/), [Orphan drug](https://onco.cc/terms/orphan-drug/), [Orphan drug designation](https://onco.cc/terms/orphan-designation/), [Real-Time Oncology Review (RTOR) and Assessment Aid](https://onco.cc/terms/real-time-oncology-review/), [Sakigake designation (Japan)](https://onco.cc/terms/sakigake/)
- key papers: [Cercek 2022: six months of dostarlimab alone made rectal cancer disappear in every patient with mismatch-repair deficiency](https://onco.cc/key-papers/paper-cercek-dostarlimab-rectal-nejm-2022/)
- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/)

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