Analysis
What the administration claimed
The FDA granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) for use in combination with nivolumab to treat adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a PD-1–blocking antibody-based regimen.
Claimant: U.S. Food and Drug Administration
Agency or office: FDA
Context
Approval is for Tudriqev in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on PD-1 blocking therapy. The approval was granted under the FDA’s accelerated approval pathway based on objective response rate and duration of response; the supporting trial reported a 24% objective response rate with median response duration of 14.1 months.
Evidence
The FDA press release explicitly states accelerated approval was granted for Tudriqev for the specified indication and cites trial results (24% objective response rate; median duration 14.1 months). Because approval is via the accelerated pathway based on response rate from a single-arm trial, confirmatory trials are required—this makes the decision consequential and somewhat controversial.