Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Aug 7
- 1 min read
Updated: 6 days ago
06/08/2026
US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma (Ref)
Replimune announced that the US FDA has granted accelerated approval for TUDRIQEV™ (vusolimogene oderparepvec-wtpg, formerly RP1; type 1 (HSV-1) oncolytic viral therapy) in combination with nivolumab for patients with unresectable advanced cutaneous Melanoma who have progressed after anti‑PD‑1 therapy
This indication is approved under accelerated approval based on objective response rate and duration of response from Ph2 IGNYTE trial
ORR: 24.2%
Median DOR: 14.1 months
Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial
Upcoming milestones:
Confirmatory Phase 3 IGNYTE‑3 trial ongoing
Launch of Replimune Connect Plus for patient support and reimbursement
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