FDA Grants Accelerated Approval to Tudriqev for Advanced Melanoma
The U.S. FDA approved Tudriqev as an innovative oncolytic HSV-1 based immunotherapy for advanced melanoma patients unresponsive to prior PD-1 inhibitors. This treatment is to be used with nivolumab in adults with unresectable advanced cutaneous melanoma. The accelerated approval follows positive clinical response data and reflects the FDA's efforts...
- Published date: 20-08-2026 10:02 AM
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral immunotherapy designed to address treatment-resistant advanced melanoma.
Tudriqev is intended for use in combination with nivolumab in adult patients with unresectable advanced cutaneous melanoma who have experienced disease progression following PD-1 inhibitor therapy. This approval marks a significant advancement in options for patients with limited remaining treatments.
The FDA's decision was based on clinical response data demonstrating the therapy's potential efficacy in this challenging population, alongside a thorough regulatory assessment to expedite availability to patients in need.