Amgen escalated its effort to settle an FDA dispute over Tavneos by submitting an independent reevaluation analysis supporting continued market access for the drug. The company said the new dataset backs its position that the rare disease therapy should remain available, following the regulator’s challenge over aspects of the evidence. The filing underscores how niche oncology and rare-disease drugs can become battlegrounds for trial interpretation, endpoints, and post-market expectations. For other sponsors with contentious safety or efficacy arguments, the package signals the importance of third-party reevaluations in ongoing regulatory negotiations. Tavneos remains the focal point of the agency-company standoff, with the next decision likely to turn on how FDA weighs Amgen’s reassessment against the concerns that prompted the dispute.