22 January 2021 - Today the FDA approved the combination of nivolumab (Opdivo, Bristol-Myers) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma.

Efficacy was evaluated in CHECKMATE-9ER, a randomised, open-label trial in patients with previously untreated advanced renal cell carcinoma.

The nivolumab review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application. Both the nivolumab and the cabozantinib applications used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately one month ahead of the FDA goal date.

The nivolumab application was granted fast track review, and both the nivolumab and cabozantinib applications were granted priority review.

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