T Vec ( talimogene laherparepvec) is filed at FDA for Metastatic Melanoma-Amgen

A Biologics License Application has recently been accepted for review by the FDA, as has a Marketing Authorization Application in the European Union, for talimogene laherparepvec from Amgen for the treatment of patients with regionally or distantly Metastatic Melanoma. The FDA has set a review goal date under the Prescription Drug User Fee Act (PDUFA) of July 28, 2015. The regulatory filings included data from more than 400 patients and is based on a global, randomized, open-label Phase III trial evaluating the safety and efficacy of intralesional talimogene laherparepvec in patients with stage IIIB, IIIC, or IV Melanoma that are not surgically resectable compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). An Amgen -sponsored expanded access protocol (EAP) is currently active for qualified patients with unresected, stage IIIB to IV Melanoma who are not eligible for or who cannot access ongoing talimogene laherparepvec trials.