A New First-line Option for Bladder Cancer Treatment

First-line nivolumab with chemotherapy was approved for bladder cancer. 

The U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma. 

Nivolumab is an immune checkpoint inhibitor, a type of immunotherapy that helps keep antitumor immune cells active so they can attack cancer cells. Nivolumab was previously approved to treat certain urothelial carcinomas after chemotherapy or surgery. The latest approval makes nivolumab, in combination with chemotherapy, available to patients who have not received any treatments for their unresectable or metastatic urothelial carcinoma. 

A new combination therapy was approved for the first-line treatment of advanced urothelial carcinoma, a type of bladder cancer. 

The approval is based on results from CHECKMATE-901, a randomized, open-label, phase III clinical trial. The trial enrolled 608 patients who had not received prior treatments for their unresectable or metastatic urothelial cancer. Patients were randomly assigned (1:1) to either the nivolumab arm (nivolumab plus cisplatin and gemcitabine, followed by nivolumab alone) or the chemotherapy only arm (cisplatin and gemcitabine). 

Patients in the nivolumab arm had significantly longer overall survival and progression-free survival than patients in the chemotherapy only arm. Those in the nivolumab arm had a median overall survival of 21.7 months and a median progression-free survival of 7.9 months compared with 18.9 months and 7.6 months, respectively, for those in the chemotherapy only arm.  

The recommended nivolumab dosage is 360 mg in combination with cisplatin and gemcitabine every three weeks for up to six cycles, followed by 240 mg every two weeks or 480 mg every four weeks as monotherapy until disease progression, unacceptable toxicity, or a maximum duration of two years after the first dose. 

Urothelial carcinoma is the most common type of bladder cancer. According to federal statistics, it was estimated that 83,190 individuals would be diagnosed with bladder cancer and 16,840 patients would die of the disease in the United States in 2024. 

The FDA rendered its decision on March 6, 2024.