FDA Approves New Immunotherapy for Advanced, Treatment-Resistant Melanoma

Written by Ted Samson

Posted on September 15, 2026

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The U.S. Food and Drug Administration (FDA) has approved vusolimogene oderparepvec-wtpg (Tudriqev) for some adults with advanced melanoma. Tudriqev is a modified virus designed to attack cancer cells and is given with nivolumab, a type of cancer immunotherapy.

The treatment is for people whose melanoma can’t be removed with surgery and has continued to grow or spread after treatment with a PD-1-blocking drug (a treatment that helps immune cells attack cancer).

The FDA granted accelerated approval based on early evidence that the treatment may benefit people with advanced melanoma. This pathway can make promising treatments available sooner for serious conditions.

🗳️ What would you most want to know about a newly approved melanoma treatment?

How well it works

Who may be eligible

How it’s given

Possible side effects

The company must complete additional studies to confirm that Tudriqev provides a clinical benefit.

What Is Tudriqev?

Tudriqev is an oncolytic viral therapy, which means it uses a modified virus to attack cancer cells. When used with nivolumab, it may also help strengthen the immune system’s response against cancer.

PD-1 is a protein on immune cells that helps keep immune responses in check. Nivolumab blocks the PD-1 pathway, while Tudriqev is designed to act directly in melanoma tumors. The goal of the combination is to help the immune system recognize and fight cancer cells.

Tudriqev is injected directly into melanoma tumors. Nivolumab is given through an IV infusion.

How Well Did Tudriqev Work in Clinical Trials?

The FDA reviewed results from a clinical trial involving 140 adults with stage 3B, 3C, or 4 melanoma that couldn’t be removed with surgery. All participants had melanoma that continued to grow or spread after at least eight weeks of treatment with an anti-PD-1 therapy.

Among the 91 participants who could be evaluated for response, 24 percent had an objective response to treatment. An objective response means tumors shrank or disappeared by a predefined amount. Responses lasted a median of 14.1 months.

A 24 percent response rate doesn’t mean that everyone will benefit or that the treatment will work the same way for each person. It also doesn’t predict an individual’s outcome.

As with any treatment, Tudriqev can cause side effects. It’s important to ask a healthcare provider about potential side effects when considering a new treatment.

Why This Approval Matters for People With Melanoma

For adults with advanced cutaneous melanoma that has progressed after PD-1 immunotherapy, Tudriqev plus nivolumab offers another treatment option. This is important because treatment choices can become more limited after melanoma stops responding to PD-1-based therapy.

Tudriqev is injected directly into tumors to help the immune system attack the cancer.

Other treatments may include lifileucel, which uses a person’s own immune cells to fight the tumor. Targeted therapies may also be an option for melanomas with certain BRAF mutations.

The FDA granted Tudriqev accelerated approval, so researchers still need to confirm its clinical benefit in additional studies. For now, the approval gives some people whose melanoma has progressed after PD-1 treatment another way to approach treatment.

If you or someone you love is living with advanced melanoma, ask your oncologist how the available treatment options — including newly approved treatments — may apply to your situation.

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