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Project FrontRunner

Advancing Development of New Oncology Therapies to the Early Clinical Setting

Project FrontRunner

What is Project FrontRunner? 

Project FrontRunner is an Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to first develop and seek approval of new cancer drugs for advanced or metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a new drug  for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. 

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

  • Earlier access to new therapies: Initiating the clinical investigation of new therapies in an earlier treatment setting can provide 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. 
  • Improved assessment of drug effects. There is greater opportunity to characterize the drug’s safety profile while avoiding the confounding effects of disease-related complications or sequelae of prior treatment.   
  • Elucidates drug effects  of new therapies compared to established standard of care. Randomized controlled trials which are the gold standard in characterizing new drug safety and effectiveness are less challenging to conduct early in the course of advanced/metastatic disease (e.g., first or second line setting) due to larger patient numbers and identifiable effective treatments to compare the new drug to, factors which may lacking in a more advanced treatment setting.
  • Potential to improve treatments in the frontline setting. With the increase in the number of approved cancer treatments, there is a need to continually optimize treatment strategies for newly diagnosed patients with metastatic disease. While treatments in the frontline setting for many diseases may provide improvements in survival, better treatment options either as add-ons to or replacements of current non-curative and often very toxic treatments. 
What are Project FrontRunner Goals?
  • Develop a framework for identifying candidate drugs that are appropriate to  initially develop for the treatment of early metastatic disease (e.g., first or second line 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 patients’ lives. 

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. 

Will FDA require that sponsors follow the Project FrontRunner paradigm? 

As is always the case, FDA provides recommendations to sponsors on the best approach to developing new drugs for the treatment of cancer. In the right context, the Project FrontRunner paradigm may be appropriate for sponsors to consider.

Could Project FrontRunner discourage sponsors from developing drugs in the more refractory settings? 

FDA recognizes the need to address the unmet need for treatments for patients who have received many prior treatments, and this will remain a priority for the OCE. Use of expedited programs that support drug development programs that address an unmet need continues to be strongly encouraged. Project FrontRunner aims to improve the evidence base for cancer therapies by promoting trial designs and clinical development and regulatory approaches (e.g., accelerated approval pathway) that help generate data from gold standard randomized controlled trials to support the safe and effective use of cancer therapies for all patients. 


Program Lead: Lola Fashoyin-Aje, MD, MPH, Associate Director (acting), Oncology Center of Excellence 
Project Management: Caitlin Drew, RN, MSN, Senior Regulatory Health Project Manager, Oncology Center of Excellence


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