FDA approves new-generation immunotherapy nivolumab for bladder cancer treatment

On 2 January 2017, the United States Food and Drug Administration (FDA) approved the new-generation immunotherapy drug nivolumab (Opdivo) for locally advanced or metastatic bladder and urinary tract cancers.

Mechanisms of action of immune checkpoint regulator immunotherapies When urinary tract cancer is mentioned, the first to come to mind is bladder cancer . Its most important risk factor is smoking . Bladder cancer is the most common urinary tract cancer and the 9th most common cancer worldwide. Also known as transitional epithelial cell cancers, urothelial cancersare the histological subtype accounting for %90 of cancers of the urinary tract outside the kidneys.

Nivolumab received FDA approval in 2015 for stage 4 kidney cancer treatment

The study leading to nivolumab’s approval for bladder cancer:

The study evaluated patients with locally advanced or metastatic urothelial cancer, 270 in total. They were selected from patients whose disease worsened (progressed) during platinum-containing chemotherapy, a mainstay of bladder cancer treatment, or who had received platinum-containing neoadjuvant treatment (to shrink the tumor before surgery) within 12 months or adjuvant treatment (a group with an aggressive disease course).

In conclusion, patients receiving nivolumab had an objective response rate of %19.6. In addition, 7 patients had a complete response and 46 had a partial response.

The most frequently reported side effects were fatigue, musculoskeletal pain, nausea and reduced appetite.

The recommended nivolumab dose and schedule is every 2 weeks, administered intravenously (into a vein), at 240 mg.