Replimune launches TUDRIQEV for advanced melanoma in the United States
Replimune Group announced that its oncolytic therapy TUDRIQEV, used together with nivolumab, is now commercially available for adult patients with unresectable advanced cutaneous melanoma who have progressed after PD‑1‑blocking treatment. The product received fast‑track FDA clearance in early August and can be ordered for next‑day delivery. The company also introduced a patient‑support program to help with access and reimbursement.
Why it matters
The launch moves Replimune from a purely clinical‑stage business to a revenue‑generating company, which could boost sales if physicians adopt the therapy. Continued FDA approval will depend on results from an ongoing confirmatory Phase 3 trial, so future revenue may be affected by those outcomes.
Key facts
- 1TUDRIQEV is indicated in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who progressed after PD‑1‑blocking therapy. globenewswire.com
- 2The FDA granted accelerated approval for the indication in early August 2026. globenewswire.com
- 3The IGNYTE trial enrolled 140 patients; 91 efficacy‑evaluable patients showed an objective response rate of 24.2% and a median duration of response of 14.1 months. globenewswire.com
- 4TUDRIQEV is administered by intratumoral injection once every two weeks for eight doses, with nivolumab starting at week three. globenewswire.com
- 5ReplimuneConnect Plus patient‑support program provides access, reimbursement and financial assistance services. globenewswire.com
- 6Replimune expects the therapy to be available for next‑day delivery to healthcare providers beginning 1 Oct 2026. globenewswire.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.