Bristol-Myers Squibb Company has announced that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
“At BMS, we hope to provide treatment options to patients with advanced forms of renal cell carcinoma,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Breakthrough therapy designation and today’s filing acceptance for the Opdivo plus Yervoy combination are an important step in our ongoing efforts to advance therapies to address a high unmet need in first-line treatment of kidney cancer in intermediate- and poor-risk patients.”
The application is based on data from the phase 3 CheckMate -214 study, which was stopped early based on the recommendation of an independent Data Monitoring Committee following a planned interim analysis of overall survival. The results of the study were recently presented at the European Society for Medical Oncology (ESMO) 2017 Congress.
The Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines with signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.