FDA approves new viral therapy for advanced skin cancer

The US Food and Drug Administration (FDA) has granted accelerated approval to a new genetically engineered viral therapy for adults with advanced melanoma whose cancer has progressed despite previous immunotherapy.

Tudriqev, also known as vusolimogene oderparepvec-wtpg, has been approved in combination with nivolumab, marketed as Opdivo, for adults with unresectable advanced cutaneous melanoma that has progressed following treatment with a PD-1-blocking antibody. The treatment was developed by biotechnology company Replimune.

Unlike conventional cancer medicines, Tudriqev is an oncolytic viral therapy that is injected directly into tumours. The genetically modified virus is designed to infect and destroy cancer cells while stimulating an immune response against the cancer.

The FDA’s decision was supported by results from the IGNYTE clinical trial. Among 91 patients included in the main efficacy analysis, 24.2% experienced an objective response to treatment, while the median duration of response among those who responded was 14.1 months.

The approval provides another treatment option for patients with advanced melanoma whose disease has continued to progress following PD-1-based immunotherapy, a group for whom treatment options can be limited.

However, Tudriqev has been granted accelerated rather than traditional approval. This allows treatments for serious conditions to reach patients based on earlier evidence of benefit, while requiring further research to confirm that benefit.

Replimune is now conducting a Phase 3 confirmatory trial examining Tudriqev in combination with nivolumab. Continued FDA approval could depend on the results of that study.

The FDA said the approval represents a new option for patients with treatment-resistant advanced melanoma and described the therapy as an engineered viral immunotherapy designed to attack tumours while activating the body’s immune response.

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