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Breakthrough Therapy, Priority Review and the Priority Voucher are FDA fast lanes for drugs that look substantially better than existing options.
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.
Sac-TMT carries T030, a belotecan-derived TOP1 inhibitor; belotecan shown.
Showing the molecule this term concerns: Sacituzumab tirumotecan.
Shares Orphan drug designation, FDASIA 2012 and the origins of the expedited programmes, FDA Oncology Center of Excellence, Incentives reward me-too drugs and marginal gains.
Shares Orphan drug, Orphan drug designation, FDA Oncology Center of Excellence, Incentives reward me-too drugs and marginal gains.
Shares Fast Track and RMAT designations, FDASIA 2012 and the origins of the expedited programmes, FDA Oncology Center of Excellence.
Shares Sakigake designation (Japan), Fast Track and RMAT designations, Regulatory divergence between regions.
Shares FDASIA 2012 and the origins of the expedited programmes, BLA / NDA / MAA (marketing applications) and PDUFA dates, FDA Oncology Center of Excellence, Regulatory divergence between regions.
Shares Real-Time Oncology Review (RTOR) and Assessment Aid, Transferable priority vouchers for first-in-class drugs, with price conditions, Sakigake designation (Japan), Fast Track and RMAT designations.
Shares Orphan drug, China Drug Administration Law (2019) and expedited pathways, Regulatory divergence between regions.
Shares Orphan drug, Orphan drug designation, Incentives reward me-too drugs and marginal gains.