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Opdivo Receives Breakthrough Therapy Status for Advanced Renal Cell Carcinoma
The FDA has granted a breakthrough therapy designation to nivolumab (Opdivo, Bristol-Myers Squibb) for the potential treatment of advanced or metastatic renal cell carcinoma (RCC).
This designation is based on results of CheckMate-025, a phase III study that evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC compared with everolimus, a current standard of care for patients with previously treated kidney cancer.
The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study had met its primary endpoint of overall survival (OS), demonstrating superior OS in patients receiving nivolumab compared with the control arm. Bristol-Myers Squibb will present data from this study at the upcoming 2015 European Cancer Congress and expects to submit these data to regulatory authorities this year.
The breakthrough therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases.
According to the FDA, the criteria for breakthrough therapy designation requires preliminary clinical evidence that demonstrates the medicine may result in substantial improvement on at least one clinically significant endpoint compared with available therapy. This is the fourth breakthrough therapy designation granted for Opdivo by the FDA. Previous indications to receive this designation include patients with Hodgkin lymphoma after failure of autologous stem-cell transplant and brentuximab, previously treated advanced melanoma, and previously treated non-squamous non–small-cell lung cancer.
Source: Bristol-Myers Squibb; September 16, 2015.