Reports reveal that Richard Pazdur, head of the FDA’s Oncology Center of Excellence, directly influenced the rejection of Replimmune’s melanoma drug RP1 by overruling the Center for Biologics Evaluation and Research (CBER) consensus recommendation for approval. This internal agency discord underscores leadership instability and regulatory challenges impacting emerging cancer therapies. The high-profile intervention exemplifies evolving dynamics between FDA centers affecting oncology drug approvals and consequent market reactions.