EU accepts filing of nivolumab for treatment of Non Small Cell Lung Cancer - BMS
BMS announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for nivolumab in Non-Small Cell Lung Cancer (NSCLC) � the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumour type. The MAA submitted to the EMA in lung cancer is based on data from the Phase II study of nivolumab in third-line pre-treated squamous cell NSCLC (Study -063) in which nivolumab met its goal of improving objective response rate in 100 patients with squamous cell NSCLC.
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