Vusolimogene oderparepvec, marketed as Tudriqev, is a genetically modified oncolytic virus therapy built from herpes simplex virus type 1 and engineered to express GM-CSF and a glycoprotein from gibbon ape leukemia virus. It is injected directly into tumors, where the virus replicates and breaks cancer cells apart while triggering the immune system to recognize and attack the cancer more broadly. The drug is indicated in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed despite prior anti-PD-1 immunotherapy. It received United States Food and Drug Administration approval in August 2026 under breakthrough therapy designation and accelerated approval, alongside nivolumab, for treatment-resistant melanoma cases.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 First Approved / Isolated Year Sources
1. Vusolimogene oderparepvec (Wikipedia)
Lead section, approval-status statementQuote, Lead section, approval-status statement
Vusolimogene oderparepvec was approved for medical use in the United States in August 2026.
2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
3. Dermatology Times: FDA Approves RP1 (Vusolimogene Oderparepvec) Plus Nivolumab for Advanced Melanoma
Approval historyQuote, Approval history
FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (RP1) in combination with nivolumab on August 6, 2026
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