Vusolimogene oderparepvec

TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

TUDRIQEV is an oncolytic viral therapy which preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R – expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote an anti-tumor immune response.

Recommended dosage of TUDRIQEV is 1 mL/cm of the largest dimension of the tumor for a maximum of 10 mL across all lesions treated with each dose. Administer intratumor injections of TUDRIQEV every two weeks for 8 consecutive doses starting at a concentration of 10 6 plaque-forming units (PFU) per mL at Week 1 followed by 10 7 PFU per mL for subsequent weeks. Administer nivolumab intravenously starting at Week 3, according to nivolumab prescribing information. See full prescribing information for TUDRIQEV preparation, and administration instructions.

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Accidental exposure to TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients. Should accidental exposure occur, clean the affected area. Herpetic infection or reactivation: Assess and treat suspected herpetic lesions as clinically warranted. Injection procedure complications, including but not limited to hemorrhage, infection, and visceral injury. Monitor patients for signs and symptoms of visceral injury during and after TUDRIQEV administration and manage according to clinical practice. Immune-mediated events: TUDRIQEV in combination with nivolumab may result in immune-mediated events.

Most common non-laboratory adverse reactions (incidence > 10%) are fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.

Antivirals: Antiviral medications may reduce the efficacy of TUDRIQEV. Delay TUDRIQEV administration for 72 hours after antivirals. Effects of Antivirals Antiviral medications may reduce the efficacy of TUDRIQEV. Patients receiving systemic antiviral treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy.

Store TUDRIQEV at -70°C to -90°C (-94°F to -130°F). If a freezer is not available, refer to Table 4 for refrigeration guidelines. Table 4: Storage of Thawed TUDRIQEV in Vial and Syringe Storage Condition Thawed Vial Prepared Syringe Refrigeration: 2°C to 8°C (36°F to 46°F) 10 6 PFU/mL vial up to 2 days 10 7 PFU/mL vial up to 4 days Use within 2 hours of preparation Room temperature: 15°C to 25°C (59°F to 77°F) 10 6 PFU/mL vial up to 12 hours 10 7 PFU/mL vial up to 24 hours Store in the original carton until use.