Advancing Development Of New Oncology Therapies: Aligning With FDA's Project FrontRunner

The FDA Oncology Center of Excellence (OCE) launched Project FrontRunner in November 2022 to expedite access to new cancer drugs for patients with early advanced metastatic cancer, diverging from traditional development pathways. This initiative aims to introduce treatments earlier in the clinical setting, focusing on clinically meaningful effects and improved safety profiles compared to existing standards. By initiating randomized trials sooner and collaborating with the FDA, sponsors can streamline the approval process from accelerated to full approval. However, careful consideration of factors such as risk tolerance, patient demographics, and target relevance is crucial.

While Project FrontRunner offers opportunities for a broader patient population, early engagement with the FDA is essential to tailor development plans. This webinar delves into the risks and rewards associated with advancing novel cancer treatments earlier in the development process for the benefit of patients, investigators, and drug developers.