The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev, a new drug for the treatment of melanoma. The therapy is based on oncolytic viruses, meaning that scientists have specifically reprogrammed the herpes simplex virus. After injection, the virus replicates directly inside melanoma cells and destroys the tumor from within, while also stimulating the body’s immune system to attack any remaining tumors.
The new drug is intended for adult patients whose tumors cannot be completely removed surgically and whose disease no longer responds to standard immunotherapy drugs. Tudriqev is part of a combination therapy and is injected directly into the tumor every two weeks. According to the FDA, beginning in the third week of treatment, patients are additionally given the standard immunotherapy drug nivolumab, further strengthening the body’s immune response against tumor cells.
The drug’s approval followed a complex review process during which the regulator twice declined to grant authorization due to insufficient data. However, following a meeting held in late July, an advisory committee voted in favor of the application. An analysis of data from 91 patients enrolled in the clinical trial showed that the tumor size was significantly reduced in 24% of cases, a result scientists refer to as an objective response. The median duration of response was 14.1 months, representing a potentially important alternative for patients who no longer benefit from treatment with standard PD-1 blockers.
The manufacturer, Replimune Inc., is required to conduct additional studies to maintain the authorization and ultimately confirm the therapy’s clinical benefit. Reported side effects included fatigue, fever, chills, and muscle and joint pain. Because the drug is viral, its safety warnings also include the risk of transmitting herpes infection to close contacts or reactivating the virus in the patient.
A full course of treatment costs $450,000, although oncology centers will help patients work with insurance funds to distribute the financial burden.
