New Tumor Injection for Advanced Melanoma After Immunotherapy Progresses

TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified oncolytic viral therapy given by intratumor injection only (not IV). On the US Package Insert it is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval may depend on confirmatory clinical benefit in confirmatory trial(s).

Distinct path — not this carton (fact-only): Other melanoma immunotherapies, checkpoint inhibitors alone, and other intralesional products (including other oncolytic viruses) have separate labels. Mucosal or uveal melanoma populations are not asserted as this labelled cutaneous unresectable advanced door on sources used here. Today’s US labelled intratumor oncolytic door with nivolumab after PD-1 progress is Replimune TUDRIQEV STN 125827.

The FDA approved STN BL 125827/0 on 6 August 2026 under accelerated approval. Approval letter issues U.S. License Number 2360 to Replimune, Inc., Woburn, MA. Letter attention: Kari Jeschke. Associated NCT numbers on the letter include NCT03767348, NCT04050436, NCT04349436. Breakthrough Therapy designation noted on the FDA oncology approval notice. Package Insert revised 8/2026. Manufactured by Replimune, Framingham, MA; marketed from Woburn, MA. (Package Insert footer shows “US License No. xxxxx” — this draft uses License 2360 from the approval letter.)

Where this is taking place

Commercial labelled door today: United States — FDA-labelled TUDRIQEV for adults with unresectable advanced cutaneous melanoma after PD-1–based progress, given as intratumor injections at an oncology / melanoma centre that can also administer nivolumab, with accidental-exposure precautions for patients and caregivers. Company materials describe ReplimuneConnect Plus for access, reimbursement, and financial-support information for eligible patients prescribed TUDRIQEV. This is a specialist oncology injection + IV immunotherapy conversation — not a retail pickup and not a DIY import.

Outside the United States: As of this draft, no confirmed Health Canada Notice of Compliance, European Commission marketing authorisation, MHRA licence, TGA listing, Swissmedic authorisation, or PMDA/MHLW licence for TUDRIQEV / vusolimogene oderparepvec. Do not import on your own.

IGNYTE — NCT03767348 — Open-label, multiregional Phase 1/2 study. Lead sponsor: Replimune, Inc. CT.gov status at draft time: ACTIVE, NOT RECRUITING. Estimated enrolment 340 (overall study). Actual start 20 Sep 2017; estimated primary completion Jun 2028; estimated study completion Dec 2028. Countries with listed sites include the United States, United Kingdom, France, Germany, and Spain. Expanded access: CT.gov reports hasExpandedAccess: false on the record retrieved for this draft. Honesty: The labelled efficacy set is a completed analysis within an ongoing program — that is not open new-enrolment for the pivotal melanoma cohort, and it is not the same sentence as “walk into any clinic for TUDRIQEV.”

IGNYTE-3 — NCT06264180 — Ongoing confirmatory Phase 3 (accelerated-approval PMR). CT.gov status: RECRUITING. Estimated enrolment 400. Sponsor: Replimune, Inc. Central contact on the record: Clinical Trials at Replimune, 1-781-222-9570, clinicaltrials@replimune.com. Countries with listed sites include the United States, United Kingdom, France, Germany, Greece, Poland, and Spain. Honesty: Confirmatory trial recruitment is not automatic commercial labelled supply; discuss both paths with the oncology team without collapsing them.

The practical commercial door in the US is a melanoma / medical oncology clinic that can confirm unresectable advanced cutaneous melanoma after PD-1 progress, identify injectable lesions, give the labelled intratumor schedule with nivolumab, teach accidental-exposure precautions, and arrange ReplimuneConnect Plus / payer logistics — not treating ACTIVE_NOT_RECRUITING as open enrolment.

Approval matrix

Access by country

• United States: Ask a melanoma / medical oncology clinic about FDA-labelled TUDRIQEV with nivolumab. Labelled 6 August 2026 (accelerated) for adults with unresectable advanced cutaneous melanoma after disease progression on a PD-1–blocking antibody-based regimen. Recommended TUDRIQEV dosage: 1 mL/cm of the largest dimension of the tumor, maximum 10 mL across all lesions per dose; intratumor injections every 2 weeks for 8 consecutive doses starting at 10⁶ PFU/mL (Week 1) then 10⁷ PFU/mL; nivolumab IV starting at Week 3 per nivolumab PI. Assess lesion size each treatment day; prioritize rapidly growing / largest injectable lesions. Vials: 10⁶ PFU/mL white-cap NDC 83616-106-01 (carton 83616-106-11); 10⁷ PFU/mL blue-cap NDC 83616-107-01 (carton 83616-107-11); 1 mL extractable volume each. Company support: ReplimuneConnect Plus (access / reimbursement / financial-support information on company materials). Suspected adverse reactions: Replimune 1-877-375-0095 or medinfo@replimune.com, or FDA MedWatch 1-800-FDA-1088. No list price or copay dollars in this article. This is US commercial labelled supply through specialist oncology, not a DIY import.

• Canada: TUDRIQEV authorisation not confirmed. Ask the Canadian oncology clinic what legal paths exist in Canada when a Canadian TUDRIQEV label does not yet exist.

• European Union / United Kingdom / Australia / Japan / other countries: Regulator authorisation not confirmed in this draft. Open or completed trial sites are not a commercial foreign carton. Do not import on your own.

• If your regulator has not authorised it: do not import on your own. Ask the local clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, confirmatory-trial eligibility (IGNYTE-3), or waiting — without treating a US vial as a foreign carton.

Who is eligible (from the US label)

This is an adult unresectable advanced cutaneous melanoma after PD-1 progress conversation on the Package Insert — intratumor oncolytic virus plus nivolumab — not a claim that overall survival benefit is already proven.

United States (Package Insert, revised August 2026):

• Indication: In combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1–blocking antibody-based regimen.
• Accelerated approval: Based on ORR and duration of response; confirmatory clinical benefit still required.
• Recommended dosage: Intratumor 1 mL/cm (max 10 mL/dose) q2wk ×8; Week 1 10⁶ PFU/mL then 10⁷ PFU/mL; nivolumab IV from Week 3.
• Contraindication: None listed on Highlights.
• Warnings: Accidental exposure / transmission risk; herpetic infection or reactivation; injection-procedure complications (hemorrhage, infection, visceral injury); immune-mediated events with nivolumab (including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, vitiligo).
• Drug interactions: Antivirals may reduce efficacy — delay TUDRIQEV 72 hours after antivirals.
• Most common non-laboratory adverse reactions (>10%): fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, abdominal pain.
• Pregnancy / lactation / contraception: Effective contraception during treatment and for 90 days after the last dose (females of reproductive potential and males with female partners); do not breastfeed during treatment and for 90 days after the last dose; males — no sperm donation during treatment and for 90 days after last dose.
• Pediatrics: Safety and effectiveness not established.
• Geriatrics: IGNYTE included adults ≥65; discuss with clinician.

IGNYTE trial context (USPI / FDA notice): Adults with Stage IIIB, IIIC, or IV unresectable advanced melanoma who progressed on at least eight consecutive weeks of prior anti-PD-1–based therapy; 140 enrolled; 91 with ≥1 non-injected lesion in the efficacy-evaluable population.

Not labelled on sources confirmed for this draft:

• Children and adolescents.
• Canadian, EU, UK, Japanese, Australian, or Swiss TUDRIQEV marketing authorisations (not confirmed here).
• Proven overall-survival benefit (still confirmatory under accelerated approval / IGNYTE-3).
• Treating NCT03767348 follow-up as open commercial enrolment.

What the pivotal study showed (Prescribing Information)

Use the Package Insert for a prescription conversation. Journals are supportive reading.

IGNYTE — NCT03767348 (USPI Study):

• Open-label, multiregional, single-arm; TUDRIQEV intratumor + nivolumab (nivolumab 240 mg IV q2 weeks for 16 weeks starting with the second TUDRIQEV dose, then 480 mg IV q4 weeks as single agent per study description on PI).
• Efficacy-evaluable: 91 patients with ≥1 non-injected lesion.

USPI Table 3 — Efficacy results:

Trial-status honesty: CT.gov status ACTIVE, NOT RECRUITING at draft time for IGNYTE. Confirmatory IGNYTE-3 (NCT06264180) is RECRUITING. Accelerated label ≠ proven survival benefit yet.

How it is taken (US label — keep this exact)

Research team (from primary sources only)

• Applicant / manufacturer / marketer: Replimune, Inc. — Framingham manufacturing; Woburn marketing; U.S. License 2360 (approval letter).
• Pivotal study sponsor: Replimune, Inc. (NCT03767348 / IGNYTE).
• Confirmatory trial sponsor / contact: Replimune, Inc. (NCT06264180 / IGNYTE-3) — Clinical Trials at Replimune 1-781-222-9570.
• Patient support (company): ReplimuneConnect Plus — access / reimbursement / financial-support information on company materials; AE / info 1-877-375-0095.
• Names and phones below are limited to what appears on the Package Insert, FDA approval notice / letter, ClinicalTrials.gov, and clearly labelled company support materials.

Sources

1. FDA — FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma (6 Aug 2026).
2. FDA — FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma (press).
3. FDA — August 6, 2026 Approval Letter — TUDRIQEV (STN BL 125827/0; License 2360).
4. FDA — TUDRIQEV Package Insert (revised 8/2026).
5. ClinicalTrials.gov — NCT03767348 (IGNYTE); NCT06264180 (IGNYTE-3).
6. Replimune — FDA accelerated approval / ReplimuneConnect Plus company materials (Aug 2026).

Not medical advice. Talk with a clinician who knows the full history before any treatment decision. Authorized is not funded.