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Amgen's First-in-Class Viral Drug, T-Vec, Could Soon Be Approved by EMA

October 23, 2015

AJMC Staff

The drug is awaiting an FDA verdict next week.

The European Medicine Agency (EMA) has approved Amgen's tumor-killing virus, talimogene laherparepvec (T-Vec) for treating unresectable melanoma that has not metastasized. Imlygic uses a modified herpes simplex virus that is targeted to infect cancer cells alone. The virus, injected directly into the tumors, replicates and causes the cancer cells to rupture. The resulting immune system response is responsible for the antigenic response against the tumor.

The product is due for an FDA verdict by October 27, 2015.