FDA Approves Replimune's Twice-Rejected Melanoma Viral Therapy Tudriqev After White House Intervention
核心洞察
The FDA approved Replimune's injected viral therapy Tudriqev (搜索) for advanced melanoma (搜索) after previously rejecting it twice over efficacy concerns.
Tudriqev (搜索) is designed for use in combination with the checkpoint inhibitor nivolumab (Opdivo) in patients with advanced melanoma (搜索).
The approval followed White House intervention and a 10–3 vote by an FDA advisory panel in favor of the drug.
The US Food and Drug Administration has granted approval to Tudriqev (搜索), an injected viral therapy for advanced melanoma (搜索) developed by Massachusetts-based Replimune, after twice rejecting the drug over efficacy concerns. The decision marks a dramatic turnaround for the therapy, which will be used in combination with the checkpoint inhibitor nivolumab, marketed as Opdivo.
The FDA first rejected Replimune's application in July 2025 and again in April 2026, citing concerns that the clinical data were insufficient and did not prove that improvements observed in patients could be attributed to Tudriqev (搜索) rather than Opdivo alone. According to the FDA's assessment, these improvements were seen in only about one-quarter of patients in a Phase 1/2 trial.
Following the second rejection, the White House intervened, according to reporting by the Wall Street Journal. That intervention ultimately led the FDA to convene a panel of outside advisers to review the application. Last month, the advisory panel voted 10–3 in favor of approving Tudriqev (搜索), paving the way for the agency's final decision.
As a condition of the approval, Replimune will still need to conduct a confirmatory study to further establish the therapy's clinical benefit. This requirement reflects the accelerated approval pathway, which allows drugs addressing serious conditions to reach the market based on surrogate endpoints while requiring post-marketing confirmatory trials.
The approval represents a significant milestone for Replimune and for the field of oncolytic viral therapy, an approach that uses genetically modified viruses to selectively infect and kill cancer cells while stimulating anti-tumor immune responses. The combination of Tudriqev (搜索) with nivolumab is designed to harness both direct tumor lysis and immune checkpoint blockade to enhance therapeutic efficacy in advanced melanoma (搜索), a disease with significant unmet need despite recent advances in immunotherapy.