FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma

The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, treatment-resistant melanoma.

Tudriqev is approved for use together with nivolumab in adult patients whose unresectable cutaneous melanoma has progressed after a PD-1 blocking antibody regimen.

Data from the supporting trial showed that roughly one in four patients achieved a response, and those responses lasted a median of almost 14 months, offering a meaningful new option for this difficult-to-treat group.

The agency also weighed input from clinical experts and patient advocates who stressed the urgent need for additional therapies, noting that the approval provides oncologists with a new tool and more patients with a fighting chance.