THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) Tuesday announced the submission of a Marketing Authorization Application or MAA to the European Medicines Agency 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 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. It is based on a global, randomized, open-label Phase 3 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.
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