FDA Approves Opdivo for Renal Cell Carcinoma

The FDA granted approval to nivolumab (Opdivo) for patients with renal cell carcinoma. Opdivo, a PD-1 inhibitor, was previously approved for the treatment of melanoma whose tumors express the BRAF V600 mutation as well as advanced non-small cell lung cancer.

About Renal Cell Carcinoma

Each year in the United States, more than 61,000 people are diagnosed with kidney cancer. The most common type of kidney cancer is renal cell carcinoma (RCC), which starts in the lining of very small tubes (tubules) in the kidney. For people with advanced RCC (cancer that has spread to other parts of the body), targeted therapies can play an important role in treatment. Approximately 20-30% of patients with RCC will have metastases at diagnosis and as many as 40% will demonstrate metastasis after primary surgical treatment for localized RCC.  With a 5-year survival rate ranging from 5-10%, the prognosis for these patients is poor. 

About Opdivo

Opdivo is a precision cancer medicine that belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Opdivo works by blocking PD-1. PD-1 inhibitors are being investigated in more than 30 different cancers, and it is already approved for the treatment of melanoma and lung cancer and researchers continue to evaluate its effectiveness in different types of cancer.

The approval was based on the results of a comparative clinical study known as CheckMate 025. Of 821 patients with advanced renal cell carcinoma who stopped responding to antiangiogenic therapies, patients were assigned to receive Opdivo or Afinitor (everolimus) a standard therapy in this setting.

The median overall survival was 25 months with Opdivo compared to 19.6 months with Afinitor.  In addition, more patients responded to the immunotherapy ― the objective response rate was 21.5% for Opdivo versus 3.9% for Afinitor. And they responded longer: the median duration of response was 23 months for patients on Opdivo versus 13.7 months for those on Afinitor.

Reference: Motzer R, Escudier B, McDermott D, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. New England Journal of Medicine. 2015. 2015DOI: 10.1056/NEJMoa1510665.

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