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FDA Gives Priority Review to Vusolimogene Oderparepvec for Melanoma
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Key Takeaways
- The FDA accepted a BLA for RP1 with nivolumab for advanced melanoma, with a decision due by July 2025.
- Melanoma is the fifth most common cancer in the US, with limited treatment options for advanced stages.
Vusolimogene oderparepvec in combination with nivolumab is being assessed to treat individuals with unresectable or metastatic stage IIIb-IV cutaneous melanoma.
A biologics license application (BLA) with priority review was accepted by the FDA for vusolimogene oderparepvec (RP1; Replimune Group, Inc.) in combination with nivolumab (Opdivo; Bristol Myers Squibb) to treat advanced melanoma. The drug has a Prescription Drug User Fee Act action date of July 22, 2025.1
Melanoma accounted for approximately 100,000 new cases and 8000 estimated deaths in the US in 2024, marking the disease as the fifth most common cancer.1 Melanoma reaches an advanced stage when the cancer has spread from where it originated to another area of the body. Although melanoma can spread almost anywhere in the body, the most common places include the lymph nodes, lungs, liver, bones, brain, and abdomen.2 Around half of patients treated with immune checkpoint blockage, the current standard of care therapy, do not respond or progress after treatment, according to study authors.1
“There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti-PD-1 containing regimen,” said Sushil Patel, PhD, Chief Executive Officer, Replimune, in a news release.1
The randomized, controlled, multicenter, open-label phase 3 confirmatory IGNYTE-3 (NCT06264180) clinical trial supported the BLA. The IGNYTE trial is ongoing and is assessing RP1 plus nivolumab in individuals with unresectable or metastatic stage IIIb-IV cutaneous melanoma who have progressed after treatment with anti-PD-1 and anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) therapies or who are ineligible for anti-CTLA-4 treatment. The IGNYTE trial is underway with over 100 sites scheduled globally. 1,3,4
RP1 is based on a proprietary strain of herpes simplex virus and is genetically prepared with a fusogenic protein, GALV-GP R- and GM-CSF. The drug is intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response, according to study authors.1
The study has 3 separate phases: a 28-day screening period, a treatment period up to approximately 2 years, and a follow-up period up to 3 years after treatment completion. Following the screenings, individuals will be randomly assigned into 1 of the 2 treatment groups—RP1 plus nivolumab or investigators choice of treatment, which is an approved standard treatment for advanced melanoma.3
RP1 dosing begins on day 1 and is administered into the tumor every 2 weeks for up to 8 cycles. Following the first dose, concurrent nivolumab infusions will begin every 2 weeks, which is then followed by dosing every 4 weeks for up to 20 months.3
“The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application,” said Patel, in a news release.1
