We note that the FDA also granted Breakthrough Therapy Designation to this dual immuno-oncology therapy for previously-treated advanced HCC patients. Shares of Bristol-Myers' shares have increased 11.9% so far this year compared with the industry 's rise of 3.7%. We note that Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries, including the United States, the EU and Japan, for several cancer indications.