TAMPA, Fla. — The Food and Drug Administration announced the expanded approval of Opdivo® (nivolumab), an immunotherapy treatment that is now available for patients with small cell lung cancer (SCLC) whose disease progressed following two or more previous therapies. Opdivo is a monoclonal antibody, delivered intravenously, that helps increase T cell activation by blocking PD-L1 (programmed cell death ligand 1). 

“Small cell lung cancer is an aggressive disease. Patients can relapse quickly and the prognosis is poor. Opdivo is the first therapy to be approved for small cell lung cancer in nearly 20 years. It gives us a new option for patients battling this disease,” said Scott J. Antonia, M.D., Ph.D., chair of Moffitt Cancer Center’s Department of Thoracic Oncology. Moffitt was one of 38 centers that participated in Bristol-Myers Squibb’s open-label phase 1/2 CheckMate-032 clinical trial that led to the drug’s approval.

The trial evaluated Opdivo alone, as well as the combination of Opdivo and Yervoy (ipilimumab) in patients with advanced or metastatic solid tumors, including SCLC. A group of 216 patients with progressive SCLC following one or more prior lines of therapy was randomized to single-agent treatment or combination. Trial results published in The Lancet Oncology show treatment with Opdivo alone led to a median overall survival of 4.4 months and a one-year overall survival rate of 33 percent.

Media Availability: Dr. Scott Antonia and a patient are available for interview; please contact Sara Bondell, 813-745-1353//Sara.Bondell@Moffitt.org

Bristol-Myers Squibb News Release: https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-firs

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 6,000 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter and YouTube