EMA Validates the Marketing Authorization Application for Nivolumab in Non-Small Cell Lung Cancer

Bristol-Myers Squibb Company (BMS) has 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 tumor type.

“Lung cancer is the leading cause of cancer death worldwide, and there remains a significant need for effective treatment options for patients with this disease,” said Michael Giordano, MD, Senior Vice President, Head of Oncology Development, BMS. “We are pleased to have two applications for nivolumab now under review in the EU, and look forward to continued collaboration with health authorities around the world as we work to bring nivolumab to patients.”

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 addition to the MAA for lung cancer in the EU, the company previously announced that it has initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end.