# Accelerated approval

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

## TL;DR

FDA approval based on early evidence (like tumour shrinkage) on condition that a confirmatory trial follows.

## Summary

United States, federal regulation and statute. Accelerated approval was created by FDA rule in December 1992 (Title 21 of the Code of Federal Regulations, part 314, subpart H for drugs and part 601, subpart E for biologics), written into section 506(c) of the Federal Food, Drug, and Cosmetic Act by the Modernization Act of 1997, and reformed by FDORA in December 2022. Primary text: the FDA accelerated approval programme page links the regulations and the statute.

Accelerated approval is the FDA route that grants approval on early evidence such as tumour shrinkage, measured by surrogate endpoints like ORR or pCR, on condition that a confirmatory trial follows. Approvals are withdrawn when confirmation fails, as with atezolizumab in TNBC after IMpassion131, belantamab in 2022 and sacituzumab in urothelial cancer, and Project Confirm and the 2023 FDORA reforms tightened the requirements. The term is referenced by the Glioma & glioblastoma entry, the drug records for Dordaviprone and Melphalan flufenamide, Project FrontRunner and Real-Time Oncology Review (RTOR). It features in the bottlenecks on trial design, regulatory divergence, prices and value and misaligned incentives, and in an idea on making post-progression sampling a condition of approval.

## Fields

- Kind: Term
- Last checked: 2026-09-04
- Also known as: accelerated approvals; accelerated-approval; Project Confirm

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)
- Wikipedia: https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)
- FDA: accelerated approval programme: https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program

## Connected records

- terms: [21st Century Cures Act](https://onco.cc/terms/21st-century-cures-act/), [Abigail Alliance v. von Eschenbach (2007)](https://onco.cc/terms/abigail-alliance/), [Basket trial](https://onco.cc/terms/basket-trial/), [Cancer Drugs Fund (England)](https://onco.cc/terms/cancer-drugs-fund/), [China Drug Administration Law (2019) and expedited pathways](https://onco.cc/terms/china-drug-administration-law/), [Conditional marketing authorisation (EU)](https://onco.cc/terms/conditional-approval/), [Confirmatory trial](https://onco.cc/terms/confirmatory-trial/), [Duration of response](https://onco.cc/terms/duration-of-response/), [Duration of response (DoR) and disease control rate (DCR)](https://onco.cc/terms/duration-of-response-term/), [Expanded access (compassionate use)](https://onco.cc/terms/expanded-access/), [External and synthetic control arms](https://onco.cc/terms/external-control-arm/), [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/), [FDORA 2022 accelerated approval reforms](https://onco.cc/terms/fdora-2022/), [Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments](https://onco.cc/terms/fdca/), [Full (traditional, regular) approval](https://onco.cc/terms/full-approval/), [Indication withdrawal](https://onco.cc/terms/approval-withdrawal/), [Japan conditional early approval and time-limited approval](https://onco.cc/terms/japan-conditional-early-approval/), [Label, indication and label expansion](https://onco.cc/terms/label-indication/), [Objective response rate (ORR)](https://onco.cc/terms/orr/), [Off-label](https://onco.cc/terms/off-label/), [Oncology drug pricing and price transparency](https://onco.cc/terms/drug-price-transparency/), [Orphan drug](https://onco.cc/terms/orphan-drug/), [Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026)](https://onco.cc/terms/pancreatic-cancer-uk-drug-access/), [Phase 1, 2 and 3 trials](https://onco.cc/terms/trial-phases/), [Project FrontRunner](https://onco.cc/terms/project-frontrunner/), [RACE for Children Act](https://onco.cc/terms/race-for-children-act/), [Real-Time Oncology Review (RTOR) and Assessment Aid](https://onco.cc/terms/real-time-oncology-review/), [Refractory](https://onco.cc/terms/refractory/), [Relapsed / refractory (R/R)](https://onco.cc/terms/relapsed-refractory/), [Right to Try Act 2018 and state right-to-try laws](https://onco.cc/terms/right-to-try/), [Sakigake designation (Japan)](https://onco.cc/terms/sakigake/), [Single-arm trial](https://onco.cc/terms/single-arm/), [Surrogate endpoint](https://onco.cc/terms/surrogate-endpoint/), [Surrogate endpoint validation: which stand-ins have earned trust](https://onco.cc/terms/surrogate-validation/), [Trial lifecycle: from protocol to label](https://onco.cc/terms/trial-lifecycle/)
- cancers: [Epithelioid sarcoma](https://onco.cc/cancers/epithelioid-sarcoma/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/)
- drugs: [Dordaviprone](https://onco.cc/drugs/dordaviprone/), [Melphalan flufenamide](https://onco.cc/drugs/melflufen/)
- trials: [IMpassion131](https://onco.cc/trials/impassion131/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- ideas: [A public registry of cancer treatments that were later shown not to work](https://onco.cc/ideas/idea-tr2-reversal-registry/), [A public rulebook for when an external or synthetic control arm is acceptable](https://onco.cc/ideas/idea-tr1-external-control-rulebook/), [An independent programme that validates surrogate endpoints, setting by setting](https://onco.cc/ideas/idea-tr1-surrogate-validation-programme/), [Cheap long-term survival follow-up by linking trial participants to registries](https://onco.cc/ideas/idea-tr1-registry-linked-os-followup/), [Conditional approvals that lapse automatically if the confirmatory trial is late](https://onco.cc/ideas/idea-reg-conditional-approval-sunset/), [Every patient on an accelerated-approval drug enrolled in a registry until confirmation](https://onco.cc/ideas/idea-data-accelerated-approval-registry-condition/), [Make post-progression sampling a condition of accelerated approval](https://onco.cc/ideas/idea-bio1-approval-linked-progression-sampling/), [Make sponsors justify every trial exclusion of older and multimorbid patients](https://onco.cc/ideas/idea-acc-broad-eligibility-as-regulatory-default/), [No accelerated approval for a combination without proof each part contributes](https://onco.cc/ideas/idea-tr2-contribution-of-components-mandate/), [Patent term extension scaled to proven survival gain](https://onco.cc/ideas/idea-fund-value-based-patent-extension/), [Provisional prices for surrogate-endpoint approvals, reset when survival data arrive](https://onco.cc/ideas/idea-reg-provisional-price-until-os/), [Reciprocal recognition of tumour-agnostic and rare-indication approvals across regulators](https://onco.cc/ideas/idea-moon-reciprocal-tumour-agnostic-approvals/), [Regulators accept shrinking of precancer as the endpoint for prevention drug approval](https://onco.cc/ideas/idea-prev-precursor-endpoints-for-approval/), [Sponsors deposit the confirmatory trial budget in escrow at accelerated approval](https://onco.cc/ideas/idea-reg-confirmatory-trial-escrow/), [Transferable priority vouchers for first-in-class drugs, with price conditions](https://onco.cc/ideas/idea-fund-conditional-transferable-voucher/)
- key papers: [ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer](https://onco.cc/key-papers/paper-ascent-nejm-2021/), [BREAKWATER: encorafenib plus cetuximab with chemotherapy as first treatment for BRAF V600E-mutated colorectal cancer](https://onco.cc/key-papers/paper-breakwater-nejm-2025/), [CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug](https://onco.cc/key-papers/paper-codebreak-200-lancet-2023/), [DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer](https://onco.cc/key-papers/paper-dellphi-301-nejm-2023/), [FDA's Project Optimus manifesto: cancer drugs are approved at doses that are too high](https://onco.cc/key-papers/paper-drug-dosing-conundrum-nejm-2021/), [Prasad: most surrogate endpoints in cancer trials correlate poorly with survival](https://onco.cc/key-papers/paper-prasad-surrogate-endpoints-jama-im-2015/), [SPEARHEAD-1: afamitresgene autoleucel, the first engineered T-cell receptor therapy approved for a solid tumour, in synovial sarcoma](https://onco.cc/key-papers/paper-spearhead-1-lancet-2024/), [SunRISe-1: TAR-200, a gemcitabine-releasing device placed in the bladder, for BCG-unresponsive non-muscle-invasive bladder cancer](https://onco.cc/key-papers/paper-sunrise-1-jco-2025/)
- institutions: [Bundesinstitut für Arzneimittel und Medizinprodukte](https://onco.cc/institutions/bfarm/), [European Medicines Agency](https://onco.cc/institutions/ema/), [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [Medicines and Healthcare products Regulatory Agency](https://onco.cc/institutions/mhra/)
- roadmaps: [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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