Replimune Group, Inc. (NASDAQ: REPL) announced that TUDRIQEV (vusolimogene oderparepvec-wtpg) is now commercially available in the United States, with next-day delivery available to healthcare providers.

TUDRIQEV is indicated in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1-blocking antibody-based regimen. The U.S. Food and Drug Administration granted accelerated approval for the therapy in early August, based on objective response rate and duration of response. Continued approval may be contingent on verification of clinical benefit in a confirmatory trial.

The accelerated approval was based on data from the IGNYTE trial's anti-PD-1-failed melanoma cohort, which enrolled 140 patients. Among 91 efficacy-evaluable patients with at least one non-injected lesion, TUDRIQEV plus nivolumab achieved an objective response rate of 24.2% (95% CI: 15.8, 34.3), with a median duration of response of 14.1 months (95% CI: 10.7, not reached). A confirmatory Phase 3 trial, IGNYTE-3 (NCT06264180), is ongoing.

TUDRIQEV is administered by direct intratumor injection once every two weeks for eight consecutive doses, with nivolumab administered intravenously beginning at week three.

Serious adverse reactions occurred in 35% of the 140 patients who received TUDRIQEV in combination with nivolumab. Adverse reactions leading to permanent discontinuation occurred in 2.9% of patients.

Replimune also launched ReplimuneConnect Plus, a patient support program offering benefits investigation, co-pay assistance for eligible commercially insured patients, and case manager support.

According to the company's press release, melanoma accounts for approximately 105,000 new U.S. cases annually and nearly 8,500 deaths per year. TUDRIQEV is Replimune's first commercially available product.