Vusolimogene oderparepvec FDA Approval Status

Last updated by Judith Stewart, BPharm on July 22, 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) accepted the Biologics License Application (BLA) vusolimogene oderparepvec in combination with nivolumab for patients with advanced melanoma.
The BLA was 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, assessed 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.
On July 22, 2025, Replimune announced that the FDA had issued a Complete Response Letter (CRL) regarding the BLA for vusolimogene oderparepvec in combination with nivolumab for the treatment of advanced melanoma. The CRL indicated that the FDA had been unable to approve the application in its present form. The FDA indicated that the IGNYTE trial had not been considered to be an adequate and well-controlled clinical investigation that provided substantial evidence of effectiveness. Furthermore, the FDA said the trial could not be adequately interpreted due to the heterogeneity of the patient population. The CRL also stated that there had been items related to the confirmatory trial study design which would need to be addressed, including contribution of components. Importantly, no safety issues were raised.
Vusolimogene oderparepvec is also being studied in non-melanoma skin cancer.

Development timeline for vusolimogene oderparepvec

Date	Article
Jul 22, 2025	Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma
Jan 21, 2025	Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
Nov 21, 2024	Replimune Receives Breakthrough Therapy Designation for RP1 and Submits RP1 Biologics License Application to the FDA under the Accelerated Approval Pathway
Jun 6, 2024	Replimune Announces Positive Topline Primary Analysis Data by Independent Central Review from IGNYTE Clinical Trial of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma
Dec 5, 2023	Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers

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