New melanoma drug based on herpes virus granted FDA accelerated approval
Federal regulators have granted accelerated approval to a novel therapy for advanced melanoma—giving doctors another weapon to fight this challenging skin cancer.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to a new melanoma drug, Tudriqev, which is an oncolytic virus therapy targeting cancer cells. This innovative treatment utilizes a modified herpes simplex virus to kill melanoma cells and stimulate the patient's immune system to attack remaining tumor cells.
Tudriqev is intended for adult patients with advanced melanoma that cannot be completely removed surgically and is not responding to standard immunotherapy drugs. The drug is administered as an injection into the tumor once every two weeks, combined with standard immunotherapy infusions that enhance the immune response against cancer cells.
After receiving accelerated approval, Tudriqev marks a significant milestone for patients with limited treatment options, as their prognosis often becomes dire when PD-1 blocking therapy stops working. Among the 91 patients in the clinical trial, 24% experienced tumor shrinkage, with the median response time being 14.1 months. However, safety concerns have been raised, including the potential for accidentally spreading herpes infections to close contacts or developing/reactivating herpes infections in patients.
Tudriqev will be priced at $450,000 per treatment course, with financial navigators available to help patients determine their out-of-pocket expenses. Confirmatory trials are required to maintain the drug's approval status.
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