Opdivo Gets Priority Review for NSCLC

BMS announced in a press release today that Opdivo (nivolumab), approved for advanced melanoma, has received priority review from the FDA for treating patients with advanced NSCLC.

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Bristol-Myers Squibb Company 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% of cases, includes three main subtypes including squamous NSCLC. Squamous NSCLC accounts for approximately 25 to 30% of all lung cancers.

Read the complete press release: