# Project FrontRunner

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

## TL;DR

An FDA initiative encouraging companies to test new cancer drugs earlier in the disease, in first-line or curative settings, rather than only after everything else has failed.

## Summary

Project FrontRunner is an FDA initiative that encourages companies to test new cancer drugs earlier in the disease course, in first-line or curative settings, rather than only after every other option has failed. Launched in 2022, it aims to shift the development of novel agents into earlier lines using randomised trials and to reduce reliance on single-arm accelerated approvals in late lines. It therefore connects the terms Accelerated approval and Lines of therapy, and it is one of the regulatory levers discussed in the bottlenecks on trial design, endpoints and cost and on incentives that reward me-too drugs and marginal gains. The BREAKWATER trial record also refers to the initiative, and readers following the regulatory thread will meet it beside Project Orbis.

## Fields

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

## Sources

- FDA Project FrontRunner: https://www.fda.gov/about-fda/oncology-center-excellence/project-frontrunner

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Lines of therapy](https://onco.cc/terms/first-line/)
- trials: [BREAKWATER](https://onco.cc/trials/breakwater/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/)

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JSON: https://onco.cc/api/v1/entities/project-frontrunner.json