Amgen files for EU approval of talimogene laherparepvec and for evolocumab

2 September 2014

Leading independent biotech firm Amgen (Nasdaq: AMGN) has submitted a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic.

Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate a systemic anti-tumor immune response. If approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies.

The MAA for talimogene laherparepvec contains data from more than 400 patients and is based on a global, randomized, open-label Phase III trial evaluating the safety and efficacy of talimogene laherparepvec in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).

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