The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev, an oncolytic virus therapy for adults with advanced melanoma that cannot be surgically removed and has progressed despite PD-1 blocking immunotherapy.
The treatment uses a herpes simplex virus engineered to replicate inside melanoma cells, destroying them and stimulating the immune system to attack remaining tumor cells.
Patients receive injections directly into the tumor every two weeks, with infusions of the immunotherapy drug nivolumab beginning in the third week of therapy.
In a clinical trial of 91 patients, 24% experienced tumor shrinkage, defined as an objective response, with a median response duration of 14.1 months.
An FDA advisory committee voted 10 to 3 in favor of approval after a review process that included previous rejections and a July 30 meeting with patient testimony.
To maintain approval, developer Replimune Inc. must conduct post-approval trials to verify clinical benefit and report results to the FDA.
Common side effects reported in the study included fatigue, fever, chills, musculoskeletal pain, nausea, diarrhea, and injection site reactions.
The FDA warns of the risk of herpes infection spreading to close contacts or reactivating in the patient; the therapy carries a list price of $450,000 per treatment course before discounts and rebates.
New melanoma drug based on herpes virus granted FDA accelerated approval
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