Replimune has launched Tudriqev (vusolimogene oderparepvec, also known as RP1) in the United States for adults with advanced melanoma that has progressed after PD-1 therapy, two months after the FDA granted it accelerated approval. The company announced on 1 October 2026 that the Tudriqev launch was under way and that the oncolytic immunotherapy, used together with nivolumab, is now commercially available with next-day delivery. The approval followed two earlier FDA rejections, which makes the launch one of the more unusual regulatory stories of the year.
Key Takeaways
- Tudriqev is available in the US from 1 October 2026, for use with nivolumab in adults with unresectable advanced cutaneous melanoma that progressed after PD-1 therapy.
- The FDA granted accelerated approval in early August 2026 (6 August in one account, 7 August in another) on the basis of response rate and duration of response.
- In the IGNYTE trial, 24.2% of 91 efficacy-evaluable patients responded, with a median duration of response of 14.1 months, according to the labelling data reported.
- Continued approval depends on confirmatory results from the Phase III IGNYTE-3 trial, with a readout reportedly expected around 2030.
- One report put the price at $450,000 per treatment course. We could not verify it against a company statement.
What Is Tudriqev and Who Is It For?
Tudriqev is an oncolytic immunotherapy, a modified virus designed to infect and destroy tumour cells and to trigger an immune response against the cancer. It is given with nivolumab, a PD-1 blocking antibody marketed by Bristol Myers Squibb as Opdivo. The approved indication is adults with unresectable advanced cutaneous melanoma that has progressed on anti-PD-1 therapy, a group with limited options once standard immunotherapy stops working.
Melanoma is a cancer that begins in pigment-producing skin cells. The National Cancer Institute provides general information on its stages and treatment. The company says the product is injected into tumours, which is typical of this drug class, and patients receive nivolumab in addition.
Tudriqev at a Glance
| Item | Detail |
|---|---|
| Product | Tudriqev (vusolimogene oderparepvec, RP1), oncolytic immunotherapy |
| Company | Replimune |
| Use | With nivolumab, adults with unresectable advanced cutaneous melanoma that progressed after anti-PD-1 therapy |
| FDA decision | Accelerated approval, early August 2026 (after complete response letters in July 2025 and April 2026) |
| US launch | 1 October 2026, next-day delivery |
| Efficacy (IGNYTE) | 24.2% objective response rate; median duration of response 14.1 months (91 evaluable of 140 enrolled) |
| Serious adverse reactions | 35% of patients; 2.9% permanent discontinuation |
| Confirmatory trial | Phase III IGNYTE-3 (NCT06264180), ongoing |
| Price | Not published by the company; one report cites $450,000 per course |
The Road to Approval: Two Rejections and an Advisory Committee Vote
The FDA issued a first complete response letter in July 2025 and a second in April 2026. Reports say the agency’s concern in the second letter was whether a single-arm study could separate the effect of the new drug from that of nivolumab alone. After the second rejection, the company criticised what it described as inconsistent communication and a fragmented, slow-moving process. An FDA advisory committee voted 10 to 3 in favour on 30 July 2026, and accelerated approval followed on the third submission.
An FDA representative called the approval an important milestone that gives oncologists a meaningful new tool for this group of patients, according to one report. Analysts quoted in that report project peak sales approaching $1 billion if confirmatory data are positive. Those are forecasts, not results.
What the Data Show
The approval rests on the IGNYTE study. Among the 91 patients who could be evaluated for efficacy out of 140 enrolled, all of whom had progressed on anti-PD-1 therapy and had non-injected lesions that could be assessed, 24.2% had an objective response and the median duration of response was 14.1 months. Reported patient characteristics include 80% with stage 4 disease and 54% with PD-L1-negative tumours.
One report cites a higher response rate of 34% and a median duration of 24.8 months from the IGNYTE study. That appears to describe a different analysis or patient subset, and we use the figures reported from the FDA-approved labelling data. Readers should note that the study was single-arm, which means there was no control group and the contribution of each drug cannot be separated.
Safety
Serious adverse reactions occurred in 35% of patients. The most common side effects included fatigue, fever, chills and musculoskeletal pain. Permanent discontinuation because of adverse reactions occurred in 2.9% of patients, and no grade 4 or 5 events were reported among the common adverse reactions. Prescribers and patients should consult the full prescribing information from the US Food and Drug Administration for warnings and precautions.
Launch, Access and Pricing
Tudriqev is now commercially available in the US, with next-day delivery, according to the company. Replimune operates a patient support program, ReplimuneConnect Plus, which offers benefits investigation, co-pay assistance for commercially insured patients and financial aid. The company has not published a list price in the announcement we reviewed. One report says the price is $450,000 per course of treatment, below the $563,000 it cites for Iovance’s Amtagvi, but this is not confirmed by the company.
What Is Not Yet Known
- Whether IGNYTE-3 will confirm the benefit and whether it will include a control comparison that addresses the FDA’s earlier concern. The trial is listed as IGNYTE-3 (NCT06264180).
- The official list price and how insurers will cover it.
- How quickly oncologists and treatment centres will adopt a tumour-injected therapy.
- Real-world safety and response outcomes outside the clinical trial.
Related Coverage
For more on cancer treatment news, see our reports on the Bristol Myers Squibb’s Relopduo launch in India for advanced melanoma, the FDA approval of Lilly’s Jaypirca in first-line CLL/SLL, Summit’s ivonescimab bladder cancer trial and Kupando’s first patient dosed with KUP101.
Our Assessment
In our assessment, the approval is a meaningful step for patients with few options after PD-1 therapy has failed, and a vindication for a company that persisted through two rejections. But it is an accelerated approval based on a single-arm study, and the confirmatory trial will decide whether Tudriqev holds its place. A launch is only the beginning of the evidence, and the long wait to the reported 2030 readout means treatment decisions will rest on limited controlled data for some years.
Frequently Asked Questions
What is Tudriqev?
It is an oncolytic immunotherapy (vusolimogene oderparepvec, or RP1) given with nivolumab for advanced melanoma that has progressed after PD-1 therapy.
When did Tudriqev launch in the US?
Replimune announced on 1 October 2026 that it is commercially available, following accelerated FDA approval in early August.
How effective is it?
In the IGNYTE trial, 24.2% of 91 evaluable patients responded and the median duration of response was 14.1 months.
Why did it take three submissions?
The FDA issued complete response letters in July 2025 and April 2026, reportedly questioning whether a single-arm study could show the effect of the new drug beyond nivolumab.
How much does it cost?
The company has not published a list price in the announcement we reviewed. One report cites $450,000 per course, which we could not confirm.
How we reported this: details come from Replimune’s launch announcement of 1 October 2026 and reports of the FDA approval, its labelling data and the regulatory history. Efficacy and safety figures are as reported and the approval is accelerated and conditional. Last updated 5 October 2026. This article is for information only and is not medical advice.
