Vusolimogene oderparepvec (RP1)

Development by disease

Upcoming events

No upcoming events with a stated date or window.

Past results and milestones

• Aug 6, 2026
  FDA granted accelerated approval for TUDRIQEV (RP1) plus nivolumab in unresectable advanced cutaneous melanoma after anti-PD-1 progression, based on IGNYTE trial showing 24.2% ORR and 14.1-month median duration of response in the efficacy-evaluable population of 91 patients. Source
• Jul 30, 2026
  FDA advisory committee voted 10-3 that the single-arm IGNYTE Phase 2 efficacy data are evaluable and clinically meaningful, supporting RP1 + nivolumab in anti-PD-1-failed advanced melanoma. The favorable vote came despite FDA staff concerns about data interpretability. Source
• Jun 26, 2026
  FDA accepted the second RP1 BLA resubmission on June 26, 2026 as a complete Class 1 response, with an August 2, 2026 action date and a late-July advisory committee meeting. Source
• May 30, 2026
  At ASCO 2026, RP1 plus nivolumab showed 47.8% 3-year overall survival in anti-PD-1-failed melanoma patients with median OS of 32.9 months; 83.5% 3-year survival among responders. Source
• Apr 10, 2026
  FDA issued Complete Response Letter on April 10, 2026, rejecting the BLA resubmission for RP1 plus nivolumab. Despite IGNYTE trial demonstrating 34% response rate with 24.8-month median duration and 30.6-month median PFS versus 4.4 months on prior PD-1 therapy, FDA determined evidence of RP1 contribution of effect was insufficient. Source
• Oct 20, 2025
  The FDA accepted the BLA resubmission for RP1 in anti-PD-1 failed melanoma in October 2025, with a PDUFA target action date of April 10, 2026 confirmed. Source
• Sep 16, 2025
  The Type A meeting with the FDA was held on September 16, 2025. The outcome was inconclusive — a path forward under the accelerated approval pathway has not been determined, and the company is still evaluating FDA feedback to identify next steps. Source
• Jul 22, 2025
  FDA issued a Complete Response Letter, declining to approve the RP1 + nivolumab BLA in its present form. The agency cited the IGNYTE trial as inadequate and not well-controlled due to patient population heterogeneity, and raised issues with confirmatory trial design; no safety concerns were identified. Source
• Oct 15, 2024
  The IGNYTE Phase 2 trial (N=140) achieved a primary endpoint ORR of 33.6% (95% CI: 25.8–42.0%), with a CR rate of 16.4% and median duration of response of 24.8 months, with no treatment-related Grade 5 events. Source

Trials