# Real-Time Oncology Review (RTOR) and Assessment Aid

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

## TL;DR

FDA processes that let reviewers start on trial data before the full application is filed, speeding approvals by months.

## Summary

Real-Time Oncology Review (RTOR) and the Assessment Aid are FDA processes that let reviewers begin work on trial data before the full application is filed, bringing approvals forward by months. RTOR, introduced in 2018, allows early submission of top-line efficacy and safety data, and the Assessment Aid is a sponsor-prepared template that streamlines the reviewers' work. Together with Breakthrough Therapy / Priority Review / Priority Voucher and Accelerated approval, these mechanisms explain why many oncology approvals arrive well before their PDUFA dates. The term is referenced from BLA / NDA / MAA (marketing applications) and PDUFA dates and belongs to the Regulatory category alongside the other FDA expedited pathways.

## Fields

- Kind: Term
- Last checked: 2026-09-08

## Sources

- FDA RTOR: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [BLA / NDA / MAA (marketing applications) and PDUFA dates](https://onco.cc/terms/bla-nda/), [Breakthrough Therapy / Priority Review / Priority Voucher](https://onco.cc/terms/breakthrough-designation/), [FDASIA 2012 and the origins of the expedited programmes](https://onco.cc/terms/fdasia-2012/)

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JSON: https://onco.cc/api/v1/entities/real-time-oncology-review.json