Replimune的TUDRIQEV获FDA加速批准用于晚期黑色素瘤

Replimune Group, Inc. (REPL) announced that the U.S. FDA has granted accelerated approval for TUDRIQEV, in combination with Nivolumab (Bristol Myers Squibb), for adults with unresectable advanced cutaneous melanoma who have progressed following anti-PD-1 antibody-based therapy.
Advanced melanoma patients often face limited treatment options, with more than half experiencing disease progression. Prognosis after progression is poor, with median overall survival typically less than one year.
TUDRIQEV (vusolimogene oderparepvec-wtpg) is an oncolytic immunotherapy based on a modified herpes simplex virus type 1 engineered to selectively replicate within tumors and stimulate an anti-tumor immune response. It is administered by intratumoral injection once every two weeks for eight doses, with dosage determined by tumor size. Nivolumab is given intravenously starting at week three.
The FDA's decision was supported by data from the IGNYTE trial which enrolled 140 patients. In the efficacy-evaluable group, TUDRIQEV plus nivolumab achieved an objective response rate of 24.2% and a median duration of response of 14.1 months. The regimen was generally well tolerated, with mostly mild-to-moderate adverse events.
"This is a transformative moment for Replimune, marking years of pioneering research to bring TUDRIQEV to patients desperately in need of new treatment options for advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune. Michael K. Wong, MD, PhD, primary investigator of the IGNYTE study, added that the therapy offers a potent oncolytic immunotherapy option across a broad patient population, with a favorable risk-benefit profile.
"This milestone give oncologists a meaningful new tool- and more patients a fighting chance," said Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research.
The approval was granted under the FDA's accelerated pathway, based on objective response rate and duration of response. Continued approval may depend on confirmatory trials to verify clinical benefit.
REPL has traded between $1.50 and $13.90 over the past year. The stock closed Thursday's trading at $12.86, up 8.71%. During the overnight trading session, the stock is at $12.73, down 1.01%.
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