FDA grants priority review to Opdivo as adjuvant treatment of urothelial carcinoma
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The FDA granted priority review to nivolumab for adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma, according to the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 immune checkpoint inhibitor.
The FDA based the priority review on results of the randomized phase 3 CheckMate -274 trial, which included 709 patients with muscle-invasive urothelial cancer at high risk for recurrence after radical surgery.
Researchers randomly assigned patients 1:1 to 240 mg nivolumab or placebo every 2 weeks for up to 1 year. DFS among all patients, as well as in the subgroup of patients whose tumors expressed PD-L1 ( 1%), served as primary endpoints. OS, nonurothelial tract RFS and disease-specific survival served as secondary endpoints.
As Healio previously reported, results showed nivolumab nearly doubled DFS compared with placebo.
“After patients undergo surgery for muscle-invasive urothelial carcinoma, they continue to face uncertainties given the high rate of disease recurrence and the lack of safe and effective treatment options,” Dana Walker, MD, MSCE, vice president and development program lead for genitourinary cancers at Bristol Myers Squibb, said in a company-issued press release. “Based on the groundbreaking disease-free survival results from CheckMate-274, we believe Opdivo has the potential to change the future of treatment for muscle-invasive urothelial carcinoma. We look forward to working with the FDA toward the goal of bringing the first adjuvant immunotherapy option to these patients in the U.S.”
The FDA is expected to make a decision on this application by Sept. 3.
The agency previously approved nivolumab for several cancer-related indications, including treatment of certain patients with melanoma, lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, locally advanced or metastatic urothelial carcinoma, metastatic colorectal cancer, hepatocellular carcinoma or esophageal squamous cell carcinoma.
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