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The Food and Drug Administration granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) combined with Opdivo (nivolumab) for adults with unresectable advanced cutaneous melanoma that progressed after prior PD-1-blocking immunotherapy.

Who qualifies for the new treatment

The approval applies to patients whose melanoma cannot be surgically removed and has worsened following treatment with a PD-1 inhibitor like Opdivo or Keytruda. These immunotherapies serve as standard first-line treatments, though some patients do not respond or experience disease progression.

Until recently, treatment options after PD-1 therapy stopped working have been limited.

How Tudriqev works

Tudriqev is a genetically modified oncolytic virus injected directly into melanoma tumors. The engineered virus infects and destroys cancer cells while stimulating an immune response against the disease. Paired with Opdivo—an immunotherapy that helps the immune system target cancer—Tudriqev is used to strengthen the body’s ability to combat tumors.

Treatment involves injections every two weeks for eight doses, with Opdivo administered intravenously starting in the third week.

Trial results behind the approval

The FDA’s decision relied on data from the IGNYTE clinical trial, which enrolled 140 adults with stage 3 or 4 unresectable melanoma that progressed after at least eight weeks of PD-1 therapy. The study focused on 91 patients who had at least one tumor that remained uninjected, allowing assessment of whether the therapy could shrink distant, untreated lesions.

A measurable reduction in tumor size occurred in 24.2% of patients. Among responders, the median duration of benefit reached 14.1 months, with some responses continuing at the time of data analysis. While not all patients benefited, the results provide a potential option for those who have exhausted other treatments.

What accelerated approval means

Tudriqev received accelerated approval, a pathway enabling promising treatments for serious conditions to reach patients faster based on early evidence. The FDA’s decision depended on tumor response rates and duration rather than overall survival data. Replimune must continue studying the combination in additional clinical trials to confirm that it provides a meaningful clinical benefit. Continued FDA approval will depend on those confirmatory results.

Potential side effects

The prescribing information warns of accidental exposure to the viral therapy, risk of herpetic infections, complications from injections, and immune-related side effects. Patients will receive close monitoring for adverse reactions, and care teams will address any issues that arise.

For patients whose melanoma progressed after PD-1 therapy, the new combination introduces a fresh possibility. Discussions with oncologists may cover eligibility, which tumors could be injected, realistic expectations, side effects to monitor, and alternative clinical trials.