04/10/2026
RP1 + nivolumab was not approved by the FDA for advanced melanoma.
The decision was based on concerns regarding the adequacy of the clinical trial design to demonstrate efficacy. No new safety signals were identified.
Additional studies are ongoing.
Details: https://www.aimatmelanoma.org/fda-does-not-approve-rp1-in-combination-with-nivolumab-for-advanced-melanoma-what-this-means-for-patients/