Approved — U.S. FDA accelerated approval (2026-08-06), advanced cutaneous melanoma that progressed after PD-1 immunotherapy U.S. launch — 2026-10-01 Japan and Europe — no approval announced as of the check date
This is news about a new melanoma drug. Tudriqev (vusolimogene oderparepvec, development name RP1), an oncolytic virus therapy for advanced cutaneous melanoma that has progressed after immunotherapy, became available in the United States on October 1, 2026, and the first patient was treated on October 6. It is given together with the immunotherapy drug nivolumab. In the IGNYTE trial, tumors shrank in about one in three patients (33.6%), and the 3-year survival rate was 47.8%.
What is new: a cancer-fighting virus injected into the tumor
Tudriqev is made from a genetically modified virus of the herpes simplex family. When injected directly into a tumor, the virus multiplies inside cancer cells and bursts them, and this helps the body's immune system recognize the cancer. The PD-1 inhibitor nivolumab (Opdivo) is added to boost that immune response further.
The U.S. FDA granted accelerated approval to this combination on August 6, 2026. Accelerated approval is based on early measures such as tumor response rate and duration of response, with survival benefit to be confirmed in a follow-up trial. The application received two complete response letters (2025 and April 2026), but after more data were submitted, an FDA advisory committee voted 10 to 3 on July 30, 2026 that its benefits outweigh its risks. It also had Breakthrough Therapy designation and priority review.
Who is eligible: cutaneous melanoma that progressed after PD-1 therapy
According to the FDA label, it is for adults with unresectable advanced cutaneous melanoma whose disease progressed on a PD-1 blocking antibody-based regimen.
- Prior BRAF-targeted therapy is not required.
- Superficial, deep and visceral lesions, including lung and liver, can be injected using imaging guidance.
- Retreatment is allowed when the doctor considers it appropriate.
- The trial enrolled patients who progressed after at least 8 weeks of PD-1 therapy.
Uveal melanoma (melanoma of the eye) is not included. Another virus therapy from the same company, RP2, is being studied for uveal melanoma in a registration-directed phase 2/3 trial (REVEAL).
IGNYTE trial results: 47.8% alive at 3 years
The evidence comes from IGNYTE (NCT03767348), a multinational single-arm trial. 140 patients with advanced melanoma that had failed immunotherapy received Tudriqev plus nivolumab. Three-year follow-up was presented at the 2026 ASCO Annual Meeting.
| Measure | Result |
|---|---|
| Objective response rate (central review, 140 patients) | 33.6% |
| Complete response (tumor no longer visible on scans) | 15.0% |
| FDA label response rate (91 patients with non-injected lesions) | 24.2% |
| Median duration of response (FDA label) | 14.1 months |
| Response rate after prior anti-CTLA-4 | 27.0% |
| Median overall survival | 32.9 months |
| 1-, 2- and 3-year survival | 75.3% · 61.5% · 47.8% |
Sources: FDA news release (2026-08-06), The ASCO Post, CancerNetwork reports on ASCO 2026 and the FDA advisory committee. These are single-arm results without a comparison group.
There are two response rates because the criteria and populations differ. To see whether lesions that were not injected also shrank, the FDA analyzed only the 91 patients who had such lesions. Even by this measure, tumors shrank in about one in four patients, which suggests the immune effect spread throughout the body.
Patients whose tumors shrank lived so long that their median survival had not been reached during follow-up, compared with 18.5 months for non-responders. The confirmatory phase 3 trial IGNYTE-3 (NCT06264180) is enrolling patients and compares the combination with physician's choice of treatment, with overall survival as the primary endpoint.
How it is given and side-effect care
Tudriqev is injected directly into tumors every 2 weeks for 8 doses in total. The volume is 1 mL per cm of the largest tumor diameter, up to 10 mL per session. The first dose uses a lower concentration, and later doses a higher one. Nivolumab is given intravenously from week 3. Tumor size is measured again on each treatment day, and the fastest-growing lesions are injected first.
In the 3-year analysis, grade 3–4 treatment-related side effects occurred in 12.8% of patients, and there were no treatment-related deaths. Common side effects were fatigue, fever, chills, flu-like symptoms and injection-site reactions, mostly mild (grade 1–2). The care team manages symptoms with medicines and schedule adjustments. Pneumothorax after lung injections was rare and mostly resolved on its own.
Because it uses a herpes-family virus, there are a few precautions. Keep the injection site covered so the virus does not spread to family members, and wait 72 hours after taking antiviral medicines before an injection. Contraception is needed during treatment and for 90 days after the last dose.
Where it is available: launched in the U.S., confirmatory trial under way
- United States: launched October 1, 2026 (approved treatment). As of the company's October 28 update, more than 15 institutions had prescribed it, and the NCCN Guidelines list it as a category 2A recommendation. The company's patient support program (ReplimuneConnect Plus) helps with insurance and cost questions.
- Clinical trial: the phase 3 IGNYTE-3 trial is enrolling. Participating countries and sites are listed on ClinicalTrials.gov.
- Japan and Europe: no approval announced as of the check date. In Japan, a different oncolytic virus, Delytact, is used for brain tumors.
For how oncolytic viruses work and other approved products, see What is oncolytic virus therapy. For personalized vaccines that reduce melanoma recurrence after surgery, see mRNA cancer vaccines. An overview of nucleic acid medicine is in Nucleic acid medicine & aptamers.
What to check and questions for your doctor
- Is my melanoma cutaneous, or did it start in a mucous membrane or the eye?
- Does my case meet the definition of progression after PD-1 therapy?
- Do I have lesions that can be injected? What imaging is used for deep lesions?
- If I am treated in the U.S., how long do I need to stay for the 8-dose schedule?
- Am I eligible for a clinical trial such as IGNYTE-3?
Frequently asked questions
Who can receive the new melanoma drug Tudriqev?
Under the FDA label, adults with unresectable advanced cutaneous melanoma that progressed on a PD-1 blocking antibody-based regimen. It is used with nivolumab.
How well did it work in immunotherapy-resistant melanoma?
In the 140-patient IGNYTE trial, the objective response rate was 33.6%, the complete response rate 15.0%, and 3-year survival 47.8%. By the FDA label measure (91 patients), the response rate was 24.2% with a median response duration of 14.1 months.
How is oncolytic virus therapy given?
It is injected directly into tumors every 2 weeks for 8 doses. Deep lesions are injected under imaging guidance, and nivolumab is given intravenously from week 3.
Is Tudriqev available in Japan?
As of the check date (2026-10-30), no approval in Japan has been announced. It is currently sold in the United States, and a confirmatory phase 3 trial is under way.
Related: What is oncolytic virus therapy · Cancer gene therapy · All nucleic acid articles
Sources
- U.S. FDA — FDA approves new engineered viral immunotherapy for patients with treatment-resistant advanced melanoma (2026-08-06)
fda.gov
Checked: 2026-10-30 - The ASCO Post — FDA approves oncolytic viral therapy with immunotherapy for advanced melanoma (2026-08)
ascopost.com
Checked: 2026-10-30 - Replimune — TUDRIQEV now available in the U.S. for advanced melanoma (2026-10-01)
finance.yahoo.com
Checked: 2026-10-30 - Replimune — Fiscal second quarter 2027 results and corporate update (2026-10-28)
globenewswire.com
Checked: 2026-10-30 - CancerNetwork — RP1/nivolumab shows OS benefit in anti-PD-1–progressed melanoma (ASCO 2026, 2026-05-31)
cancernetwork.com
Checked: 2026-10-30 - CancerNetwork — FDA advisory committee backs RP1/nivolumab for advanced melanoma (2026-07-30)
cancernetwork.com
Checked: 2026-10-30 - ClinicalTrials.gov — NCT03767348: IGNYTE / NCT06264180: IGNYTE-3
clinicaltrials.gov/study/NCT06264180
Checked: 2026-10-30
Written by the FTH editorial team. Sources checked 2026-10-30 · Medical review: not applicable
This article is general information based on public sources and does not replace diagnosis or treatment. Please discuss treatment decisions with your medical team.
