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FDA grants priority review to Opdivo for advanced renal cell carcinoma

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The FDA today granted priority review to nivolumab for the treatment of patients with advanced renal cell carcinoma who received prior anti-angiogenic therapy, according to a press release from the drug’s manufacturer.

“There remains a significant unmet medical need for advanced renal cell carcinoma patients who have received prior therapy and are often repeatedly treated with agents that are similar in mechanism,” Michael Giordano, MD, head of oncology development at Bristol-Myers Squibb, said in the release. “We are pleased the FDA has accepted our [supplemental biologics license application] for Opdivo in [renal cell carcinoma], and we will continue to work with urgency to bring Opdivo to patients with this cancer.”

The FDA is expected to make a decision about approval by March.

The FDA based its decision on results of CheckMate 025, a randomized, open-label, phase 3 trial designed to compare nivolumab (Opdivo, Bristol-Myers Squibb) with everolimus (Afinitor, Novartis) in patients with advanced, previously treated renal cell carcinoma.

Researchers randomly assigned patients to a treatment regimen of IV nivolumab (3 mg/kg every 2 weeks) or oral everolimus (10 mg once daily).

OS served as the primary endpoint. Objective response rate and safety served as secondary endpoints.

Participants assigned nivolumab achieved longer median OS (25 months vs. 19.6 months; HR = 0.73; 98.5% CI, 0.57-0.93).

Further, more patients assigned nivolumab responded to treatment than patients assigned everolimus (25% vs. 5%; OR = 5.98; 95% CI, 3.68-9.72). Median PFS appeared comparable in both arms (4.6 months vs. 4.4 months; HR = 0.88; 95% CI, 0.75-1.03).

Researchers stopped the trial early in July 2015 because an assessment conducted by an independent committee concluded that the study met its primary endpoint.

Nineteen percent of the nivolumab arm experienced treatment-related grade 3 or grade 4 adverse events, compared with 37% of the everolimus arm. Fatigue was the most common adverse event associated with nivolumab (2%), whereas anemia was the most common adverse event associated with everolimus (8%).

No treatment-related deaths occurred in the nivolumab arm and two treatment-related deaths occurred in the everolimus arm.