Advocates Renew Call for RP1 Approval

As the U.S. Food and Drug Administration approaches a pivotal decision on a potential new treatment for advanced melanoma, patient advocates are once again raising their voices—this time with even greater urgency.

The following letter, sent on March 26, 2026, to FDA leadership, reflects the lived realities of patients facing anti–PD-1 refractory metastatic melanoma. It underscores both the promise of RP1 in combination with nivolumab and the profound human cost of delay.

In the months since the FDA’s initial decision in July 2025, thousands of lives have been lost to melanoma in the United States. Behind each number is a person, a family, and a story marked by hope, uncertainty, and the urgent need for more effective treatment options. For this community, access to new therapies is not abstract—it is deeply personal and time-sensitive.

This letter is more than a policy appeal. It is a reflection of patient voices—fearful, frustrated, and determined—calling for timely action in the regulatory process.

We invite you to read the full letter below.