U.S. Food and Drug Administration accepts Biologics Licensing Application for Opdivo (nivolumab) for the treatment of advanced squamous non-small cell lung cancer

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015.

In the U.S., lung cancer is one of the leading causes of cancer deaths. Non-small cell lung cancer, one of the most common types accounting for approximately 85 percent of cases, includes three main subtypes including squamous NSCLC. Squamous NSCLC accounts for approximately 25 to 30 percent of all lung cancers.

“With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,” said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb. “As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.”

Today’s filing acceptance is based on submission of clinical data from CheckMate -063, a Phase II single arm, open-label study designed to assess advanced squamous NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy.