The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma. Tudriqev 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.

The approval is supported by data from a clinical trial showing that one in four patients responded to treatment, with responses lasting a median of nearly 14 months, offering clinicians a meaningful new tool for a patient population. In reaching this decision, the FDA also considered input from clinical experts and patient advocates who emphasized the urgent need for effective options in this refractory population.

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