Amgen gets European approval for Imlygic

The European Commission has approved US biotech major Amgen’s (Nasdaq: AMGN) 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 the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase III clinical trial.

“As the first oncolytic immunotherapy authorized in the European Union, the approval of Imlygic is an important milestone for this new class of drugs, bringing patients with a rare and deadly form of skin cancer a much needed new treatment option,” said Sean Harper, executive vice president of R&D at Amgen, adding: “By igniting the body’s own immune system Imlygic can initiate an anti-tumor immune response, providing meaningful and durable response rates in the early stage metastatic melanoma patient.”

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