Key Takeaways:
The FDA granted accelerated approval to Replimune's oncolytic virus Tudriqev plus nivolumab for advanced melanoma, the company said Thursday.
"For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited," Karim Mikhail, acting director of the FDA's Center for Biologics Evaluation and Research, said. "Today's important milestone gives oncologists a meaningful new tool — and more patients a fighting chance."
The IGNYTE trial enrolled 140 patients, with 91 in the efficacy-evaluable population. Tudriqev plus nivolumab achieved an objective response rate of 24.2 percent, with a median duration of response of 14.1 months. The population included 80 percent with Stage 4 disease, 54 percent with PD-L1 negative status, and 45 percent with lung lesions.
The approval follows two complete response letters in July 2025 and April 2026, when the FDA said the single-arm study was not adequate to establish effectiveness. An advisory committee voted 10-3 last week that the trial results were clinically meaningful. Replimune shares rose nearly 9 percent to $12.86 on Thursday.
Tudriqev (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus type 1 that is injected directly into tumors, where it replicates and destroys cancer cells while triggering a systemic immune response. It is administered every two weeks for eight doses, with nivolumab introduced intravenously at week three.
More than half of advanced melanoma patients progress within six months of checkpoint inhibitor treatment, and median overall survival falls below one year after progression. Melanoma accounts for roughly 105,000 new US cases and about 8,500 deaths annually.
The approval makes Tudriqev the second FDA-cleared option for patients who stop responding to immunotherapy, after Iovance Biotherapeutics' Amtagvi, a cell therapy approved in 2024 that generated $220 million in sales last year. Leerink Partners analyst Daina Graybosch projected peak annual sales of $618 million for Tudriqev, below Wall Street's consensus near $1 billion.
Continued approval depends on the ongoing Phase 3 IGNYTE-3 trial, which compares Tudriqev plus nivolumab with physician's choice of therapy, with results expected in late 2027. Replimune, based in Woburn, Massachusetts, will market the drug alongside Bristol Myers Squibb's Opdivo.
This article is for informational purposes only and does not constitute investment advice.
