Talimogene Laherparepvec

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

  1. abdominal pain
  2. arthralgia
  3. atopic dermatitis
  4. chills
  5. constipation
  6. diarrhea
  7. dizziness
  8. fever
  9. glomerulonephritis
  10. headache
  11. impaired wound healing
  12. infection
  13. influenza
  14. injection site reaction
  15. keratitis
  16. myalgia
  17. nausea
  18. pneumonitis
  19. psoriasis
  20. pulmonary toxicity
  21. rash
  22. skin discoloration
  23. skin ulcer
  24. thrombosis
  25. tissue necrosis
  26. vasculitis
  27. vomiting
  28. 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
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