FDA Approves New Option for Urothelial Carcinoma

The FDA has expanded the use of  Opdivo (nivolumab) for the treatment of patients with urothelial carcinoma, the most common form of bladder cancer, who experience disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The drug was already approved for the treatment of advanced melanoma, lung cancer, kidney cancer, and Hodgkin lymphoma.

The approval was based on the results of a single-arm study of 270 patients. Participants received 3 mg/kg of nivolumab every 2 weeks until disease progression or unacceptable levels of toxicity.

Overall, patients demonstrated a response rate of 19.6%—7 patients achieved complete response and 46 achieved partial response over a median of 10.3 months.

The most common adverse events included fatigue, musculoskeletal pain, nausea, and decreased appetite.

—Michael Potts

Reference:

Bristol-Myers Squibb. Bristol-Myers Squibb Receives FDA approval for Opdivo (nivolumab) in previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer [press release]. Princeton, NJ. February 2, 2017. http://news.bms.com/press-release/bladdercancer/bristol-myers-squibb-receives-fda-approval-opdivo-nivolumab-previously-t&t=636217128154178578.