EC OKs Amgen’s ImmunotherapyBy
The European Commission (EC) has approved Amgen’s Imlygic (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease.
Imlygic is derived from the herpes simplex type 1 virus (HSV-1) , commonly called the cold sore virus. Imlygic has been modified to replicate within tumors and to produce the immune stimulatory protein human granulocyte-macrophage colony-stimulating factor. Administered via intralesional injection, Imlygic is designed to cause the death of tumor cells and initiate an anti-tumor immune response.
The EC approval grants a centralized marketing authorization in the 28 countries that are members of the European Union. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
In the US, Imlygic is indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.