FDA Responds to Patient Advocacy on RP1 + Nivolumab

As part of our continued advocacy for patients with advanced melanoma, we are sharing the U.S. Food and Drug Administration’s response to our September 4, 2025, letter regarding RP1 in combination with nivolumab.

Dated February 5, 2026, this reply from the Center for Biologics Evaluation and Research (CBER) acknowledges the voices of patients and families who are navigating the realities of treatment-resistant disease. It reflects recognition from the agency of the profound human impact behind regulatory decisions, particularly for those who have exhausted first-line immunotherapy options.

While the FDA is limited in what it can disclose during an active review process, this response underscores the importance of patient perspectives in shaping how therapies are evaluated. It also serves as a reminder that advocacy—through letters, stories, and shared experiences—continues to play a critical role in ensuring that the needs of the melanoma community remain visible.

We invite you to read the FDA’s full response below.