The breakthrough therapy designation is given to speed up the development and review of medicines with early signals of possible clinical benefit in serious diseases to make sure patients have access to new therapies as early as possible.
A phase 3 study evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC with everolimus, an existing standard of care for patients with previously treated kidney cancer.
The study met its main endpoint of overall survival, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm.
The company aims to submit the data to regulatory authorities this year. The FDA has already approved Opdivo as a monotherapy in two cancer indications.
Bristol-Myers Squibb senior vice president, head of Development, Oncology said: "Results from CheckMate -025 mark the third tumor in which Opdivo has shown an overall survival benefit in a Phase 3 trial.
"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 accounting for over 100,000 deaths globally year. It is twice as common in men as it is in women, with the highest rates of the disease identified in North America and Europe.