FDA Grants Accelerated Approval for New Engineered Viral Immunotherapy for Advanced Melanoma

The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, for the treatment of adult patients with unresectable advanced cutaneous melanoma who have experienced disease progression with a PD-1-blocking antibody-based regimen. This approval is based on objective response rate and duration of response, with post-approval trials required to verify clinical benefit.