European approval of Bristol-Myers' Opdivo remains elusive

• Despite being on the agenda at this month's meeting of the European Medicines Agency to review new drugs, committee members reached no decision regarding Bristol-Myers Squibb's (BMY +1.2%) Marketing Authorization Application (MAA) for Opdivo (nivolumab) for the treatment of advanced melanoma. Such delays occur when reviewers feel that they need more time to evaluate the drug. The MAA could be considered again as early as next month. The agency accepted the application for review in September 2014.
• The FDA approved Opdivo in December 2014.
• Previously: EMA accepts Opdivo MAA (Sept. 29, 2014)