WASHINGTON, D.C. — The U.S. Food and Drug Administration granted accelerated approval to Replimune Inc.’s Tudriqev in combination with nivolumab for adults with unresectable advanced melanoma that progressed after PD-1-based treatment, adding a new option for patients whose cancer has stopped responding to a major class of immunotherapy.
Tudriqev, or vusolimogene oderparepvec-wtpg, is a genetically modified oncolytic viral therapy derived from herpes simplex virus type 1. It is injected directly into tumors and is designed to destroy cancer cells while stimulating an immune response against the tumor.
The approval applies to adults with unresectable advanced cutaneous melanoma whose disease progressed while receiving a programmed death receptor-1, or PD-1, blocking antibody regimen.
The FDA based the accelerated approval on an open-label, multiregional, single-arm study involving 140 adults with Stage IIIB, IIIC or IV unresectable melanoma who had experienced progression after at least eight consecutive weeks of prior anti-PD-1 therapy.
Among 91 patients evaluated for effectiveness, 24% achieved an objective response. The median duration of response was 14.1 months.
“For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited,” Karim Mikhail, acting director of the FDA’s Center for Biologics Evaluation and Research, said.
Tudriqev is administered directly into tumors every two weeks for eight consecutive doses. The first injection uses a lower concentration, followed by a higher concentration for subsequent doses, with dosage volume based on tumor size.
Nivolumab is administered intravenously beginning in the third week of treatment.
The modified virus is engineered to replicate within cancer cells and cause them to break apart while promoting immune recognition of the tumor. The combination with nivolumab is intended to restore an anti-tumor immune response in patients whose disease had previously become resistant to checkpoint-blocking therapy.
The most common adverse reactions, occurring in more than 10% of patients, included fatigue, fever, infections, chills, musculoskeletal pain, nausea, diarrhea, injection-site reactions, headache, cough, influenza-like illness, rash, vomiting and itching.
Other commonly reported reactions included joint pain, constipation, decreased appetite, dizziness, shortness of breath, hemorrhage, edema and abdominal pain.
The prescribing information includes warnings about accidental transmission of herpes infection to close contacts, development or reactivation of herpes infection in treated patients and complications associated with the injection procedure.
The FDA convened its Cellular, Tissue, and Gene Therapies Advisory Committee on July 30 to review the application, including testimony from patients, advocates, clinicians and independent experts.
Tudriqev previously received Breakthrough Therapy and Priority Review designations.
Because the drug was cleared under the accelerated approval pathway based on response rate and duration of response, Replimune must conduct post-approval studies to confirm its clinical benefit. Continued approval may depend on the results of those trials.
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