Replimune Announces TUDRIQEV™ Now Available in the U.S. for Advanced Melanoma
Replimune's TUDRIQEV is now commercially available in the U.S. for adult patients with unresectable advanced cutaneous melanoma who progressed on a PD-1-blocking regimen, in combination with nivolumab. This is the company's first marketed product, approved under accelerated FDA approval in early August based on the IGNYTE trial, where TUDRIQEV plus nivolumab achieved a 24.2% objective response rate with 14.1-month median duration of response in anti-PD-1-failed patients. Providers can order TUDRIQEV for next-day delivery, and ReplimuneConnect Plus offers patient support including co-pay assistance and reimbursement services.
Key figures
- Drug Name
- TUDRIQEV (vusolimogene oderparepvec-wtpg)
- Phase Of Trial
- Phase 3
- Orr
- 24.2%
- Trial enrollment
- 140
- Median dor months
- 14.1
- Confirmatory trial
- IGNYTE-3 (NCT06264180)
AI analysis
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