What's on this Page
What is Talimogene Laherparepvec
Talimogene laherparepvec (Imlygic; T-VEC) is a live, attenuated HSV-1 that has been genetically modified to express human GM-CSF, indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
In a multicenter, randomized, open-label clinical trial, the primary outcome of durable response rate (complete or partial response, maintained for at least 6 months) was 16.3% in patients treated with talimogene laherparepvec compared with 2.1% of those who received GM-CSF (relative risk, 7.6; p < 0.0001); the median time to talimogene laherparepvec response was 4.1 (range, 1.2 to 16.7) months.
Talimogene laherparepvec has not been shown to improve overall survival or have an effect on visceral metastases.
Talimogene laherparepvec received FDA approval in October 2015.
Brand Name
Imlygic
Indications
- malignant melanoma
Side Effects
- abdominal pain
- arthralgia
- atopic dermatitis
- chills
- constipation
- diarrhea
- dizziness
- fever
- glomerulonephritis
- headache
- impaired wound healing
- infection
- influenza
- injection site reaction
- keratitis
- myalgia
- nausea
- pneumonitis
- psoriasis
- pulmonary toxicity
- rash
- skin discoloration
- skin ulcer
- thrombosis
- tissue necrosis
- vasculitis
- vomiting
- weight loss
Contraindications
- accidental exposure
- acquired immunodeficiency syndrome (AIDS)
- autoimmune disease
- bone marrow suppression
- breast-feeding
- chemotherapy
- contraception requirements
- corticosteroid therapy
- diabetes mellitus
- geriatric
- herpes infection
- herpes simplex keratitis (dendritic keratitis)
- human immunodeficiency virus (HIV) infection
- hypogammaglobulinemia
- immunosuppression
- leukemia
- lymphoma
- multiple myeloma
- ocular exposure
- organ transplant
- peripheral vascular disease
- pregnancy
- pulmonary toxicity
- radiation therapy
- renal failure
- reproductive risk
Interactions
- Acyclovir
- Amantadine
- Antivirals
- Atazanavir; Cobicistat
- Cidofovir
- Cobicistat
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Famciclovir
- Foscarnet
- Ganciclovir
- Interferon Alfa-2b; Ribavirin
- Palifermin
- Penicillamine
- Ribavirin
- Rimantadine
- Tuberculin Purified Protein Derivative, PPD
- Valacyclovir
- Valganciclovir