- The FDA has approved Bristol-Myers Squibb's Opdivo (nivolumab) for second-line treatment of patients with advanced renal cell carcinoma (RCC), after treatment with anti-angiogenic agents is no longer effective.
- This is the third indication for Opdivo, which is already FDA-approved for the treatment of melanoma and non-small cell lung cancer (NSCLC).
- According to the National Cancer Institute, there will be roughly 61,560 new cases of RCC this year, and 14,080 related deaths.
One of the best parts about the advent of immuno-oncology is the possibility of treating different tumor types with one agent. In the case of Opdivo, it's not only the fact that it's approved for treatment of three different types of cancer, but that it is the first approved therapy since 2007 to demonstrate the ability to extend life since 2007.
In a open-label, randomized clinical trial involving 821 patients with RCC, median overall survival of Opdivo-treated RCC patients was 25 months versus 19.6 months for Afinitor (everolimus)-treated patients.
In addition, 21.5% of Opdivo-treated patients had complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9% of Afinitor-treated patients, who enjoyed this benefit for a 13.7 months on average.