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The FDA’s Oncology Center of Excellence (OCE) is shifting the paradigm in cancer treatment development with Project FrontRunner— an initiative designed to encourage drug sponsors to develop, test, and seek approval of new cancer drugs for advanced or metastatic disease and to treat patients in an earlier clinical setting (e.g., first or second line).
Traditionally, new cancer drugs are tested in patients with relapsed or refractory disease, largely due to the unmet need for treatment options, ethical concerns about exposing newly diagnosed patients to therapies that may be ineffective, and the potential for earlier market access through the accelerated approval pathway. Project FrontRunner challenges that model, urging drug developers to conduct randomized clinical trials (RCTs) in first- or second-line treatment settings. This shift aims to improve patient outcomes and create a more robust understanding of drug safety and effectiveness.
👉 Why Earlier Matters
Developing therapies as an earlier line of treatment offers multiple benefits:
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Patients gain earlier access to potentially life-saving or less toxic treatments.
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Sponsors tap into a larger patient pool and generate stronger evidence through comparative studies.
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RCTs in early settings offer clearer data on drug impact versus standard of care treatments.
👉 Aligning with Accelerated Approval
Project FrontRunner also enhances the Accelerated Approval pathway by promoting well-controlled trials over single-arm studies. This reduces uncertainty and supports faster confirmation of a drug’s clinical benefit—potentially speeding up the transition from accelerated to full approval.
👉 A Collaborative, Voluntary Framework
Sponsors are not required to follow Project FrontRunner, but by being open to the paradigm, sponsors may benefit from early collaboration with the FDA, guidance on trial design, and an accelerated pathway to approval. Patients benefit from novel treatments sooner, and companies gain clarity and strategic advantage in development.
Ready to learn more?
You can read the full article that delves deeper into Project FrontRunner’s framework, regulatory considerations, and Veristat’s expert insights on navigating this evolving landscape here: FDA’s Project FrontRunner Explained
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