medcelerator · clinician one-pager
New Tumor Injection for Advanced Melanoma After Immunotherapy Progresses
TUDRIQEV (vusolimogene oderparepvec-wtpg) — engineered virus injected into tumors plus nivolumab for unresectable advanced cutaneous melanoma after PD-1 therapy progress
FDA Approved · United States · September 11, 2026
Condition: Melanoma
Who this is for
This is for adults with unresectable advanced cutaneous melanoma whose cancer progressed on a PD-1 immunotherapy and who may be candidates for labelled US TUDRIQEV injections into tumors together with IV nivolumab. It explains the accelerated FDA approval, the IGNYTE response numbers, accidental-exposure and infection watchpoints, ReplimuneConnect Plus support, and how to talk with a melanoma oncology team — without treating confirmatory survival results as already proven, a DIY import as a plan, or “approved” as the same thing as funded. Authorized is not funded.
Next clinical step
The US Food and Drug Administration (FDA) has approved this medicine. In the United States, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma
United States · Recruiting clinical trial
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]
Tests this treatment. Vusolimogene + nivolumab after anti-PD-1 and anti-CTLA-4, label population (phase 3).
https://clinicaltrials.gov/study/NCT06264180
United States · Recruiting clinical trial
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
Combination or different setting. RP1 in primary melanoma before sentinel node biopsy (early phase 1).
https://clinicaltrials.gov/study/NCT06216938
See all 2 trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=melanoma&intr=vusolimogene%20oderparepvec&aggFilters=status:rec
General resources for further research
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/tudriqev-vusolimogene-oderparepvec