FDA Approves Nivolumab for Urothelial Carcinoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who progress during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.¹

Approval was based on findings from the international, single-arm, phase 2 CheckMate 275 study (ClinicalTrials.gov Identifier: NCT02387996), which demonstrated clinical activity and safety of nivolumab among patients with metastatic or surgically unresectable locally advanced transitional cell carcinoma of the urothelium involving the bladder, urethra, ureter, or renal pelvis.

Nearly 20% (95% CI, 15.1-24.9) of patients achieved an objective response, confirmed by an independent radiographic review committee. Seven patients had complete responses and 46 had partial responses. Estimated median response duration was 10.3 months, with responses ongoing at the time of analysis.

The most frequently reported adverse events were fatigue, musculoskeletal pain, nausea, and decreased appetite. Four patients died from treatment-related adverse events including pneumonitis and cardiovascular failure. Seventeen percent discontinued nivolumab due to adverse events.

The recommended dose and schedule for nivolumab for this indication is 240 mg intravenously every 2 weeks.

Continued approval for this indication is contingent on verification of clinical benefit in confirmatory studies.

Reference

1. Nivolumab for treatment of urothelial carcinoma. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm. Published February 2, 2017. Accessed February 2, 2017.