The US FDA has approved vusolimogene oderparepvec-wtpg (tudriqev), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who have progressed on a PD-1–blocking antibody regimen. This approval is granted under accelerated approval based on objective response rate (ORR) and duration of response.
Mechanism of Action Vusolimogene oderparepvec-wtpg is a genetically modified oncolytic viral therapy designed for intratumoral administration, leading to tumor cell lysis and activation of anti-tumor immune responses. Clinical Evidence Approval is based on objective response rate (ORR) and duration of response observed in clinical studies in patients with advanced melanoma previously treated with PD-1 inhibitors, with an ORR of 24.2% and a median duration of response of 14.1 months; continued…
