The FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with advanced skin melanoma that cannot be removed by surgery and has grown after treatment with a PD-1–blocking immunotherapy. The approval gives some patients whose melanoma has progressed on this type of treatment another option to discuss with their care team.
How the treatment works
Tudriqev is a genetically modified virus that is injected directly into tumors. It is designed to break apart cancer cells and prompt an immune response. Nivolumab is an immunotherapy that blocks PD-1, a protein that can prevent immune cells from attacking cancer. In the approved regimen, Tudriqev is injected every two weeks for eight doses; nivolumab is given through a vein beginning in week three.
What the study found
The approval was based on the IGNYTE study, which enrolled 140 adults whose advanced melanoma had progressed after prior PD-1–based treatment. The FDA’s effectiveness analysis included 91 patients who had at least one tumor that was not injected with Tudriqev. About 24% of those patients had a measurable reduction in cancer, and among patients who responded, the response lasted a median of 14.1 months.
The study did not compare the combination directly with another treatment. Accelerated approval means the FDA allowed its use based on how many patients responded and how long responses lasted. Replimune must conduct further trials to confirm the treatment’s clinical benefit; continued approval may depend on those results.
Safety and patient questions
Commonly reported side effects included fatigue, fever, chills, infections, nausea, diarrhea and reactions at the injection site. The FDA also warns about herpes infection or reactivation, accidental exposure to the virus, complications from tumor injections and immune-related side effects. Patients should tell their care team about new symptoms and ask how to care for injection sites and protect close contacts.
For someone whose melanoma has grown despite PD-1 treatment, the key question is whether their disease and overall health make this combination appropriate. Their oncology team can explain which tumors could be injected, what follow-up treatment involves and how the potential benefits and risks compare with other available options.
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