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News From the Food and Drug Administration
December 1, 2015

New Approaches for Melanoma

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(21):2227. doi:10.1001/jama.2015.15988

The FDA has approved the first oncolytic virus therapy for treating melanoma in the skin and lymph nodes that can’t be surgically removed (

Talimogene laherparepvec, marketed as Imlygic, is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein—granulocyte-macrophage colony-stimulating factor (GM-CSF).

When injected directly into melanoma lesions, talimogene laherparepvec causes tumors to rupture and die. The process releases tumor-derived antigens that, together with GM-CSF, may promote an antitumor immune response. However, investigators are still working to determine the drug’s exact mechanism of action.

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