The U.S. Food and Drug Administration (FDA) has awarded Replimune, Inc. accelerated approval for Tudriqev (vusolimogene oderparepvec-wtpg), offering a new option for patients with treatment-resistant advanced melanoma. Favorable findings from a clinical trial and insights from clinical experts and patient advocates led to the approval.

According to the FDA, Tudriqev is a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma. It works by targeting and destroying cancer cells, and “triggering the body’s immune system to recognize and attack the cancer.” It is meant to be combined with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. Since Tudriqev is based on a modified herpes simplex virus type 1, it is important to be aware of the risk of developing and/or spreading a herpes infection.

Patients receive eight doses of Tudriqev directly into their tumors. More than 10% of trial participants experienced adverse reactions including fatigue, fever, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza-like illness, rash, vomiting, itching, arthralgia, constipation, appetite suppression, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.