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Opdivo receives FDA breakthrough therapy designation for advanced RCC
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The FDA granted breakthrough therapy designation to nivolumab for the treatment of patients with advanced or metastatic renal cell carcinoma.
The FDA based its decision in part on the results of the phase 3 CheckMate-025 trial. Researchers compared nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — with standard-of-care everolimus (Afinitor, Novartis) in patients with previously treated advanced or metastatic clear-cell renal cell carcinoma (RCC). The trial was stopped early in July because patients who received nivolumab demonstrated superior OS, the trial’s primary endpoint.
Researchers will present additional data from this study at the 2015 European Cancer Congress, according to a press release.
Nivolumab is currently approved for the treatment of patients with unresectable or metastatic melanoma who experienced disease progression following treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) or a BRAF inhibitor if BRAF positive. The agent is also approved for the treatment of patients with metastatic squamous non–small cell lung cancer who progressed on or after platinum-based chemotherapy.
“Results from CheckMate-025 mark the third tumor in which Opdivo has shown an OS benefit in a phase 3 trial,” Michael Giordano, senior vice president and head of development of oncology at Bristol-Myers Squibb, said in the release. “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."