Reports revealed FDA Oncology Center of Excellence director Richard Pazdur intervened in the late stage review of Replimmune’s melanoma therapy RP1, leading to its rejection despite earlier support from the Center for Biologics Evaluation and Research (CBER). Internal agency dynamics and leadership changes contributed to regulatory turmoil affecting CGT developers such as Sarepta and Capricor. The episode underscores regulatory complexities in oncologic drug approvals and the impact of leadership decisions on biotech investments and patient access.