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Bristol-Myers: EMA Validates Marketing Authorization Application For Nivolumab(dpa-AFX International Compact Via Acquire Media NewsEdge) NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) said that the European Medicines Agency or EMA has validated for review the Marketing Authorization Application or MAA for nivolumab in non-small cell lung cancer or 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, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb. The MAA submitted to the EMA in lung cancer is based on data from the Phase 2 study of nivolumabin third-line pre-treated squamous cell NSCLC. Further to the MAA for lung cancer in the E.U., the firm announced earlier that it has begun 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. Copyright RTT News/dpa-AFX |