How To Advance New Cancer Therapies In Alignment With FDA Project FrontRunner

In a recent webinar, regulatory and clinical experts provided insights into advancing cancer therapies through FDA’s Project FrontRunner (PFR). PFR is a forward-looking initiative aimed at accelerating approval and access to oncology treatments by optimizing dose and trial design, integrating biomarker-based studies, and facilitating earlier investigational therapy options for patients with high unmet needs. The session explored biomarker endpoints, patient safety, and seamless study transitions from accelerated to full approval. It highlighted strategic considerations for sponsors, such as implementing randomized, dose-optimized designs and leveraging Decentralized Clinical Trials (DCT) to enhance site and patient involvement. Additionally, speakers addressed the importance of engaging with FDA on development plans to align with oncology guidelines (e.g., Project Optimus) and discussed the role of confirmatory trials in securing full approval.