Summary
On August 6, 2026, the FDA granted accelerated approval to Replimune’s TUDRIQEV (vusolimogene oderparepvec-wtpg), formerly known as RP1, in combination with Bristol Myers Squibb’s OPDIVO (nivolumab).
The therapy is indicated for adults with unresectable, advanced cutaneous melanoma whose disease has progressed after prior anti-PD-1 treatment.
The approval followed two previous FDA rejections, in July 2025 and April 2026, making it a significant regulatory breakthrough for Replimune.
The approval is based on tumor response data rather than confirmed overall survival benefits. Continued approval depends on results from the ongoing Phase 3 IGNYTE-3 c...
