Bristol-Myers Squibb received Breakthrough Therapy Designation this week from the U.S. Food and Drug Administration (FDA) for its Opdivo kidney-cancer test drug.
Opdivo is a treatment candidate for use against advanced renal cell carcinoma (RCC). The designation comes after results of a CheckMate -025 Phase 3 study that ended in July after survivability endpoint goals were met. To obtain this designation, a treatment candidate is required to show significant clinical evidence of its efficacy over current treatments for the condition. The company said this is the fourth Breakthrough Therapy Designation obtained for Opdivo.
“Results from CheckMate -025 mark the third tumor in which Opdivo has shown an overall survival benefit in a Phase 3 trial," Michael Giordano , Bristol-Myers Squibb's senior vice president and head of development in oncology, said. "The Breakthrough Therapy Designation in advanced renal cell carcinoma is a clear signal of the need for additional treatment approaches for RCC and reflects part of our broad commitment to immuno-oncology research that may address many types of advanced cancers."
RCC is among the most common types of cancer, and approximately 100,000 deaths are attributed to RCC on an annual basis globally. Advanced stages of RCC have a survivability rate of 12.8 percent, the company said.