Tudriqev uses an engineered herpes virus to destroy melanoma cells and trigger an immune attack after programmed cell death protein 1 (PD-1) treatment fails.
- Tudriqev is a new virus-based treatment for advanced melanoma after PD-1 therapy stops working
- The FDA approved Tudriqev with nivolumab after the drug was rejected twice earlier
- The treatment uses a modified herpes virus to attack cancer cells and activate the immune system
A genetically modified herpes virus has received FDA approval for advanced melanoma that no longer responds to PD-1 immunotherapy, giving patients with treatment-resistant disease a new treatment option.
The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), an engineered oncolytic viral therapy, for adults with unresectable advanced cutaneous melanoma whose cancer has progressed after a PD-1-blocking treatment (1✔ ✔Trusted Source
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
), (2✔ ✔Trusted Source
FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma
).
Tudriqev is used in combination with the immunotherapy nivolumab.
The treatment works differently from conventional cancer drugs. It uses a modified form of herpes simplex virus type 1 (HSV-1) to enter tumor cells, destroy them and stimulate the immune system to attack the cancer.
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How Can Tudriqev Fight Melanoma?
Tudriqev is an oncolytic viral therapy, meaning it uses a modified virus to attack cancer cells.
It is based on herpes simplex virus type 1 (HSV-1), but the virus has been genetically modified for cancer treatment.
Its action can be understood in a few simple steps:
|
Treatment Step |
Mechanism of Action |
|
Tumor injection |
Tudriqev is injected directly into the melanoma tumor and enters cancer cells. |
|
Viral replication |
The genetically modified HSV-1 replicates inside the cancer cells. |
|
Cancer cell destruction |
Viral replication causes infected tumor cells to rupture. |
|
Immune activation |
The destruction of cancer cells releases signals that help alert the immune system. |
|
Systemic immune response |
The activated immune system can recognize and attack cancer cells beyond the injected tumor. |
|
Nivolumab combination |
Nivolumab blocks the PD-1 immune checkpoint, helping strengthen the anti-tumor immune response. |
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Why Does Advanced Melanoma Become Hard to Treat?
Advanced melanoma can become difficult to control when cancer cells stop responding to treatment or find ways to escape the immune system.
Tudriqev is intended for adults whose advanced melanoma has continued to grow despite this type of immunotherapy. These patients have limited treatment options, which is why the FDA considered the need for new therapies when reviewing the drug.
The need for better treatments is also reflected in the growing melanoma burden. According to the Melanoma Research Alliance (MRA) (4✔ ✔Trusted Source
Over 112,000 Americans Estimated to Be Diagnosed with Invasive Melanoma in 2026
- 112,000 new invasive melanoma cases are expected in the US in 2026.
- About 8,510 deaths are projected.
- Melanoma is expected to be the fourth most common cancer in US men and fifth in women.
- Five-year survival for metastatic melanoma has improved from 15% in the mid-2000s to 35% during 2015–2021.
Despite these advances, treatment resistance remains a major challenge. This is where Tudriqev’s different approach, using an engineered virus to attack tumor cells and stimulate the immune system, could offer another option.
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What Did the Tudriqev Trial Show About Treatment Response?
The FDA based its accelerated approval on the IGNYTE trial, which included adults with advanced melanoma that had continued to progress despite anti-PD-1 treatment. The key findings can be understood more easily through the numbers below (3✔ ✔Trusted Source
RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE)
).
IGNYTE Trial Results: The Numbers Behind the Approval
|
Finding |
What the number means |
|
140 patients |
Adults with Stage IIIB, IIIC or IV unresectable melanoma were enrolled after their cancer progressed despite at least 8 weeks of anti-PD-1 therapy. |
|
91 patients |
These patients had at least one non-injected tumor and were included in the FDA’s efficacy analysis. |
|
24.2% response rate |
About 1 in 4 evaluable patients had their tumors shrink or otherwise meet the criteria for an objective response. |
|
14.1 months |
The median duration of response in the FDA analysis, meaning responses lasted about 14 months for the middle patient in the responding group. |
|
32.9% response rate |
The peer-reviewed Journal of Clinical Oncology analysis reported responses in about 1 in 3 patients in its analyzed population. |
|
33.7 months |
The JCO study reported a median response duration of nearly 3 years in its analysis. |
|
Non-injected tumors responded |
Some tumors that were not directly injected with Tudriqev also responded, suggesting an immune effect beyond the treated tumor. |
Some patients with melanoma that had stopped responding to PD-1 therapy experienced meaningful and sometimes long-lasting responses.
The findings also provide an important clue about how Tudriqev may work. Responses in non-injected tumors suggest that the treatment may do more than destroy the tumor where the virus is injected; it may also help stimulate an immune response against cancer elsewhere in the body.
What Does FDA’s Accelerated Approval Really Mean?
The word “accelerated” is important.
Tudriqev’s approval was based on objective response rate and duration of response, rather than definitive confirmation of long-term clinical benefit.
Under the accelerated approval pathway, Replimune must conduct post-approval studies to verify and describe the treatment’s clinical benefit. The FDA states that continued approval may depend on the results of these confirmatory trials.
The treatment schedule is also quite specific.
According to the FDA:
- Tudriqev is injected directly into tumors every two weeks.
- Treatment consists of eight consecutive doses.
- The first dose uses a lower viral concentration, followed by a higher concentration for subsequent doses.
- Nivolumab is given intravenously from Week 3.
- The amount of Tudriqev injected depends on tumor size.
This means the therapy is not a simple replacement for an existing oral or intravenous cancer drug. It requires tumors that are suitable for direct injection and administration by trained healthcare professionals.
What Side Effects and Safety Concerns Should Patients Know?
Because Tudriqev uses a genetically modified virus, its safety considerations are different from those of many standard cancer medicines.
The FDA lists common adverse reactions, including:
- Fatigue
- Fever and chills
- Infections
- Muscle and joint pain
- Nausea and diarrhea
- Injection-site reactions
- Headache
- Cough
- Rash
- Vomiting
- Reduced appetite
- Shortness of breath
- Swelling
- Abdominal pain
There are also specific warnings related to the therapy’s viral nature.
The FDA warns about:
- Accidental exposure and possible transmission of herpes infection to close contacts
- Herpes infection or reactivation in the patient
- Complications related to the injection procedure
- Immune-mediated adverse events
This does not mean Tudriqev behaves like an ordinary herpes infection. The virus has been genetically engineered for cancer treatment. However, because it is derived from HSV-1, appropriate precautions are necessary during treatment.
Frequently Asked Questions
Q: What is Tudriqev?
A: Tudriqev is a genetically modified HSV-1-based oncolytic viral therapy approved with nivolumab for certain adults with advanced melanoma after progression on anti-PD-1 therapy.
Q: How does Tudriqev kill cancer cells?
A: The engineered virus enters susceptible tumor cells and replicates inside them, helping destroy the cancer cells while also stimulating an immune response.
Q: Is Tudriqev a herpes treatment?
A: No. Although it is derived from HSV-1, Tudriqev is an engineered cancer therapy specifically developed to attack tumors.
Q: Who is Tudriqev approved for?
A: It is approved in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed on an anti-PD-1-based regimen.
Q: How effective was Tudriqev in the FDA analysis?
A: The FDA’s efficacy analysis found an objective response rate of 24.2%, with a median duration of response of 14.1 months.
Q: Does Tudriqev have to be injected directly into the tumor?
A: Yes. Tudriqev is administered by intratumoral injection, making the treatment different from medicines that are given only by mouth or through a vein.
References:
- FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma – (https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma)
- FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma – (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma)
- RP1 Combined With Nivolumab in Advanced Anti–PD-1–Failed Melanoma (IGNYTE) – (https://ascopubs.org/doi/10.1200/JCO-25-01346)
- Over 112,000 Americans Estimated to Be Diagnosed with Invasive Melanoma in 2026 – (https://www.curemelanoma.org/blog/over-112-000-americans-estimated-to-be-diagnosed-with-invasive-melanoma-in-2026)
Source-Medindia