US FDA expands use of Bristol-Myers' Opdivo to NSCLC

The US Food and Drug Administration late yesterday expanded the approved use of pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. B-MS shares rallied 6.1% to $65.67 on the news.

The FDA announcement came three months ahead of the agency’s deadline for reviewing the drug and just two months after a clinical trial of Opdivo was stopped early because of a significant improvement in survival. Lung cancer is the leading cause of cancer death in the USA, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. The most common type of lung cancer, NSCLC affects seven out of eight lung cancer patients, occurring when cancer forms in the cells of the lung.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials,” he added.