FDA’s Project Frontrunner Explained
The FDA's Project FrontRunner encourages pharmaceutical companies to test and seek approval for new cancer drugs in earlier treatment settings (such as first or second line therapy) rather than just in relapsed/refractory patients, using randomized clinical trials to potentially improve patient outcomes through earlier access to effective therapies. Veristat has summarized the key learning points below:
- Project FrontRunner aims to reduce reliance on single-arm trials for accelerated approvals by promoting randomized controlled trials that better demonstrate safety and efficacy compared to standard treatments.
- The initiative benefits multiple stakeholders: patients receive experimental treatments earlier in their disease course, while pharmaceutical sponsors gain access to larger patient populations and opportunities for more comprehensive safety profiling.
- While participation in Project FrontRunner is voluntary, early engagement with the FDA about clinical development planning can help sponsors optimize their approval pathway and potentially reduce time from accelerated approval to confirmation.
Download our white paper to learn more.
downloadExplore Our Key Related Services
Oncology | Strategic Consulting | Regulatory Affairs (overview)
Please fill out this form to access your resource.