Feature|Articles|August 18, 2026

As RP1 Heads For Melanoma Clinics, Experts Look to Streamline Rollout and Rethink Response Criteria

Author(s)Jonah Feldman, Vincent Ma, MD, Michael K. K. Wong, MD, PhD

After FDA approval of RP1 plus nivolumab, melanoma specialists now look toward preparing for clinical use and consider the future of intratumoral therapy trials.

After a nearly 2-year regulatory saga that included 2 complete response letters (CRLs), a contentious advisory committee meeting, and an outpouring of support from the melanoma community, the oncolytic therapy vusolimogene oderparepvec (RP1; Tudriqev), received accelerated FDA approval on August 6 in combination with nivolumab (Opdivo) for patients with advanced melanoma who have progressed on anti–PD-1 therapy.¹ As of August 14, RP1 is anticipated to have a product commercially available within 60 days.²