FDA grants accelerated approval to Tudriqev for PD-1-refractory advanced melanoma
- nuaxia
- 7 août
- 2 min de lecture
The engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy.
The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed on a PD-1-blocking antibody-based regimen.
The approval introduces an engineered oncolytic viral immunotherapy for this treatment-resistant population, with continued approval dependent on confirmation of clinical benefit in post-approval trials.
Field | Content |
Alert Type | Drug Approval |
Drug Name | Tudriqev (vusolimogene oderparepvec-wtpg) |
Indication | In combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1-blocking antibody-based regimen. (U.S. Food and Drug Administration) |
Therapy Area(s) | Oncology; Melanoma |
Geography | United States (FDA) |
What Happened | On 6 August 2026, the FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), Replimune's genetically modified oncolytic viral therapy, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed following PD-1-based therapy. Tudriqev is a modified herpes simplex virus type 1 (HSV-1) injected directly into tumours and engineered to destroy cancer cells while stimulating an anti-tumour immune response. The application received Breakthrough Therapy and Priority Review designations. (U.S. Food and Drug Administration) |
Why It Matters | Patients whose advanced melanoma progresses despite PD-1-based immunotherapy have a need for additional effective treatment options. Tudriqev provides a new approach combining direct tumour injection with systemic nivolumab and is intended to stimulate an immune response in disease that has stopped responding to previous immunotherapy; however, the approval is based on response data rather than confirmed survival benefit. (U.S. Food and Drug Administration) |
Supporting Context | In an open-label, single-arm trial enrolling 140 adults with Stage IIIB, IIIC or IV unresectable melanoma that had progressed following prior anti-PD-1-based therapy, 91 patients were evaluable for efficacy. The objective response rate was 24%, with a median duration of response of 14.1 months. Important safety warnings include possible herpes infection or reactivation, accidental transmission of herpes infection to close contacts and complications associated with the injection procedure. (U.S. Food and Drug Administration) |
Key Takeaway | Tudriqev provides a new FDA-approved viral immunotherapy option for adults with unresectable advanced melanoma whose disease has progressed despite PD-1-based treatment. |
What to Watch | Replimune must conduct post-approval trial or trials to verify Tudriqev's clinical benefit, and continued approval may depend on the results of this confirmatory evidence. (U.S. Food and Drug Administration) |
Primary Source | |
Relevant Date | 6 August 2026 |
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