FDA Approves Opdivo to Treat Certain Forms of Kidney Cancer
The Food and Drug Administration (FDA) has approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer.
Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body's immune system fight cancer cells. Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells).
"Opdivo provides an important therapy option for patients with renal cell carcinoma," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "It is one of few therapies that have demonstrated the ability to extend patients' survival in treating this disease."
The safety and efficacy of Opdivo for this use were demonstrated in an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent. Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with the alternative.
The FDA granted the Opdivo application a breakthrough therapy designation, fast track designation, and priority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.
Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. The National Cancer Institute estimates 61,560 new cases and 14,080 deaths from kidney and renal pelvis cancer in the United States this year.
In addition to use in the treatment of renal cell carcinoma, Opdivo has been approved to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC).