OnCo
termsTerm

Breakthrough Therapy / Priority Review / Priority Voucher

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

Breakthrough Therapy (2012) gives intensive guidance; Priority Review shortens review to 6 months; the 2025 Commissioner's National Priority Voucher pilot promises 1-2 month reviews for selected products (sac-TMT received one in July 2026).

Regulatory: what this kind of term is about · animated schematic, not to scale
Category
Regulatory

Key papers

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rctNew England Journal of Medicine 2022changed practice
Dostarlimab alone cures mismatch-repair-deficient rectal cancer without surgery or radiotherapy

Patients with rectal cancer whose tumour is mismatch-repair deficient (about 5-10% of rectal cancers) can now be offered immunotherapy alone with the realistic expectation of avoiding surgery, radiotherapy and a permanent stoma. This requires mismatch repair testing on the diagnostic biopsy, close endoscopic and MRI surveillance, and treatment in an experienced centre. It does not apply to the 90% of rectal cancers that are mismatch-repair proficient.

Connected

11top

drugs

1
Under reviewADC
Sacituzumab tirumotecan

institutions

1
FDA Oncology Center of Excellence

terms

5
BLA / NDA / MAA (marketing applications) and PDUFA datesFast Track and RMAT designationsOrphan drugOrphan drug designationReal-Time Oncology Review (RTOR) and Assessment Aid

ideas

1
Transferable priority vouchers for first-in-class drugs, with price conditions

bottlenecks

2
Incentives reward me-too drugs and marginal gainsRegulatory divergence between regions

key papers

1
Dostarlimab alone cures mismatch-repair-deficient rectal cancer without surgery or radiotherapy