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  1. Oncology Center of Excellence

Project FrontRunner

Advancing Development of New Oncology Therapies to the Early Clinical Setting

 OCE Project FrontRunner

What is Project FrontRunner? 

Project FrontRunner is an Oncology Center of Excellence initiative to encourage drug sponsors to consider when it may be appropriate to deviate from the current paradigm for developing new oncology drugs, whereby approval is typically first sought for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options, followed by approval in the earlier clinical setting. 

Designing trials that support initial approval in the earlier setting has the following advantages: 

  • Provides earlier access to new therapies: Initiating the clinical investigation of new therapies earlier in an earlier treatment setting provides more patients the opportunity to receive the investigational agent early enough in the disease course when disease-related factors do not preclude participation in the trial, and when the treatment has the potential to alter the course of the disease more effectively. 
  • Provides a better assessment of drug effects. There is greater opportunity to study the drug in a way that allows for a better assessment of the safety profile of the drug while avoiding the confounding effect of the associated complications related to the disease or to prior treatment, when new therapies are evaluated earlier in the course of the disease.   
  • Allows for comparison of new therapies to established standard of care. Developing drugs in a latter treatment setting can be challenging because there may not be identifiable effective treatments to compare the new drug to. In an earlier treatment setting, comparisons to the standard of care may be more feasible to accomplish. 
  • Addresses unmet medical need for better treatments in the frontline setting. With the increase in the number of approved cancer treatments, there is a need to assess unmet need in the frontline setting to ensure that the most beneficial treatments are being provided upfront, replacing less effective, and potentially more toxic therapies. 

What are Project FrontRunner Goals?

  • Develop a framework for identifying candidate drugs for initial clinical development in the earlier advanced setting, taking into account clinical, scientific, regulatory, and operational considerations. 
  • Facilitate engagement with drug sponsors during drug development to develop and implement strategies to support approvals in early clinical setting. 
  • Engage and collaborate with internal and external stakeholders on related research, policy, and educational initiatives. 

What is the Scope of Project FrontRunner? 

The initial focus for Project FrontRunner is for drugs being developed for treatment in the advanced/metastatic setting, typically where treatment is not expected to be curative. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of life of patients living with cancer. 

Will FDA incorporate external stakeholder perspectives in Project FrontRunner related activities? 

FDA continues to identify mechanisms to engage with stakeholders to understand the opportunities and potential challenges related to this drug development paradigm, through symposia and listening sessions, and through collaborative projects with stakeholders. 


Program Lead: Lola Fashoyin-Aje, MD, MPH, Associate Director, Science & Policy Program to Address Disparities, Oncology Center of Excellence 

Project Management: Caitlin Drew, RN, MSN, Senior Regulatory Health Project Manager, Oncology Center of Excellence

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