The U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to Replimune Group Inc. (NASDAQ: REPL ) for its Tudriqev (vusolimogene oderparepvec-wtpg), a novel oncolytic immunotherapy.
It is designated for adults suffering from unresectable advanced cutaneous melanoma that has worsened following an anti-PD-1 antibody regimen .
Promising Clinical Trial Results
This accelerated FDA nod relies on the objective response rate and response duration from the IGNYTE trial. Among 140 enrolled participants, 91 were evaluated for efficacy.
This specific group achieved a 24.2% objective response rate when treated with the Tudriqev and nivolumab combination, boasting a median response duration of 14.1 months.
Retaining this indication approval will require additional validation of clinical benefits in future confirmatory studies.
In June, Replimune presented final data from its Phase 1 study of RP2, an oncolytic immunotherapy, at the American Society of Clinical Oncology (ASCO) annual meeting.
The company said RP2 monotherapy achieved an objective response rate (ORR) of 19%. RP2 in combination with nivolumab achieved an ORR of 19.1%, with a disease control rate of 48.9%.
Median duration of response (DOR) was not reached in the monotherapy group and was 22.1 months in the combination group.
Administration And Safety Profile
Medical professionals administer Tudriqev directly into tumors via injection, utilizing specialized imaging technology for deeper visceral lesions once every two weeks for eight consecutive doses.
The size of the tumor determines the dosage amount.
A lower concentration is used for the first dose, followed by a higher concentration for all remaining doses. A second drug, nivolumab, is given intravenously beginning at week three of treatment.
In April, Replimune received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application.
Replimune highlighted what it described as inconsistencies in the FDA’s review process, challenging the agency’s assessment of its data package .
In June 2025, the FDA rejected RP1, indicating that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness .
REPL Stock Price Activity: Replimune Group shares were down 5.01% at $12.21 during premarket trading on Friday, according to Benzinga Pro data .
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