This episode examines four recent FDA regulatory interactions that advanced clinical development pathways through surrogate endpoint validation and trial design optimization. Coverage includes PDS Biotech’s VERSATILE-003 amendment prioritizing progression-free survival for accelerated approval in HPV16-positive head and neck cancer, Plus Therapeutics’ Type B meeting guidance on overall survival endpoints for rhenium Re 186 obisbemeda in leptomeningeal metastases, Rapport Therapeutics’ Phase 3 clearance for RAP-219 in focal onset seizures, and 4Moving Biotech’s IND clearance enabling US expansion of the INFLAM MOTION trial for intra-articular GLP-1 therapy in knee osteoarthritis. The briefing highlights evolving FDA standards for accelerated approval structures, surrogate biomarker qualification, and multi-jurisdictional trial execution across oncology, neurology, and rare disease programs.
