Imlygic
Unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Initial dose: Up to 4 mL of 10⁶ PFU/mL injected intratumorally
Second dose (3 weeks later): Up to 4 mL of 10⁸ PFU/mL
Subsequent doses: Up to 4 mL of 10⁸ PFU/mL every 2 weeks
Inject largest lesion(s) first, then remaining lesions. Volume per lesion based on size (0.1 mL for ≤0.5 cm to 4 mL for >5 cm).
Continue for minimum 6 months unless other treatment required or no injectable lesions remain.
Injection: 10⁶ PFU/mL (1 mL vial) for initial dose; 10⁸ PFU/mL (1 mL vial) for subsequent doses
Immunocompromised patients (including those with HIV/AIDS, leukemia, lymphoma, on immunosuppressive therapy). Pregnant women.
- Herpetic Infection: Accidental exposure may lead to herpes infection. Healthcare providers and close contacts should avoid direct contact with injected lesions, dressings, or body fluids. Use universal precautions.
- Injection Site Complications: Necrosis or ulceration at injection site. Impaired wound healing in lesions that necrose.
- Immune-Mediated Events: Vitiligo, vasculitis, pneumonitis, glomerulonephritis, worsening psoriasis reported.
- Plasmacytoma: Has been reported.
Fatigue (50%), chills (49%), pyrexia (43%), nausea (36%), influenza-like illness (30%), injection site pain (28%), vomiting (21%), headache (19%), diarrhea (19%), myalgia (18%), arthralgia (12%), pain in extremity (11%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Talimogene laherparepvec (T-VEC) is a genetically modified herpes simplex virus type 1 (HSV-1). Key modifications: (1) Deletion of ICP34.5 (neurovirulence factor) limits replication to tumor cells while sparing normal cells; (2) Deletion of ICP47 prevents inhibition of antigen presentation and drives expression of US11 early, which promotes viral replication selectively in tumor cells; (3) Insertion of human GM-CSF gene — expressed upon viral replication, GM-CSF recruits and activates dendritic cells, promoting systemic anti-tumor immune responses. The virus lyses tumor cells directly (oncolytic effect) while simultaneously releasing tumor antigens and GM-CSF to stimulate systemic immunity (abscopal effect).
Not applicable — local injection of live virus. Viral shedding from injection site detected in 3% of swabbed lesions. Viremia not detected. Biodistribution limited primarily to injection site.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
- OPTiM — T-VEC vs. GM-CSF in unresectable stage IIIB-IV melanoma. Phase III, n=436.