U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Non-Squamous Non-Small Cell Lung Cancer Patients

Bristol-Myers Squibb Company

today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC). This sBLA seeks to expand the current indication for Opdivo in patients with previously treated squamous (SQ) NSCLC. The projected FDA action date is January 2, 2016. The agency has also granted this application priority review, and Opdivo Breakthrough Therapy Designation for this indication, underscoring the need for new treatments for this patient population, where currently a significant unmet medical need remains. According to the FDA, the criteria for Breakthrough Therapy Designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. "We are pleased with this important step forward in the FDA's consideration to expand the use of Opdivo to include non-squamous non-small cell lung cancer patients, as well as the Breakthrough Therapy Designation," said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. "From its inception, our clinical development program for Opdivo in lung cancer has been based on our deep scientific expertise and always with the goal of helping patients achieve gains in survival. We look forward to working with the FDA to make this treatment option available to more patients." The submission is based on CheckMate -057, a Phase 3 study that evaluated the survival of patients with NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The positive results of a separate study, Checkmate -017, formed the basis of the current lung cancer indication; study -017 evaluated the survival of patients with SQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. In both studies Opdivo demonstrated an overall survival benefit.