FDA OKs Amgen’s Oncolytic Viral Therapy

The US Food and Drug Administration (FDA) has approved Amgen’s Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. Imlygic is manufactured by BioVex Inc., a subsidiary of Amgen.

Imlygic, a genetically modified live oncolytic herpes virus therapy, is used to treat melanoma lesions that cannot be removed completely by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die.

Amgen also reports that Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending Imlygic be granted approval 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. Following this CHMP opinion, Amgen expects a decision on the marketing authorization from the European Commission in the coming months. Imlygic is also under review by the US Food and Drug Administration.

Amgen intends to make Imlygic available to patients in the US within a week. Amgen anticipates the average cost of the therapy to be approximately $65,000. Imlygic is an oncolytic viral therapy, and Amgen expects variability of dosing from patient to patient. Therefore, Amgen intends to work with the healthcare community to implement a program that helps limit the average cost of the therapy to $65,000 for eligible participating institutions and to provide various assistance programs in support of the therapy.

Source: FDA, Amgen (US approval) and Amgen (EMA recommendation)

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