Vusolimogene oderparepvec FDA Approval Status
Last updated by Judith Stewart, BPharm on July 21, 2025.
FDA Approved: No
Generic name: vusolimogene oderparepvec
Company: Replimune Group, Inc.
Treatment for: Melanoma
Vusolimogene oderparepvec (RP1) is a next-generation HSV-1-based oncolytic immunotherapy in development for the treatment of advanced melanoma.
- Melanoma is a type of skin cancer that begins in the melanocytes. Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment.
- Vusolimogene oderparepvec is an oncolytic immunotherapy based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
- The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) vusolimogene oderparepvec in combination with nivolumab for patients with advanced melanoma.
- The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating vusolimogene oderparepvec combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3, is currently assessing vusolimogene oderparepvec in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment.
- The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025.
- Vusolimogene oderparepvec is also being studied in non-melanoma skin cancer.
Development timeline for vusolimogene oderparepvec
Further information
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