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FDA Approves Nivolumab for Urothelial Carcinoma

FDA The FDA has granted an accelerated approval to nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy, based on findings from a phase II CheckMate-275 study.

In the study, which was presented at the 2016 ESMO Annual Meeting, the objective response rate (ORR) was 19.6% for nivolumab in patients with platinum-refractory metastatic urothelial carcinoma. The complete response rate was 3%. Across the 270-patient study, the median progression-free survival (PFS) was 2.0 months and the median overall survival (OS) was 8.74 months.

The open-label study enrolled 270 patients with metastatic or unresectable urothelial carcinoma. Patients had received a platinum-based agent in the metastatic setting or were within one year of neoadjuvant/adjuvant platinum therapy. Nivolumab was administered at 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity.

The median age of patients was 66 years and 84.1% of patients had visceral metastases at baseline. Overall, 42.2% of patients had received 1 prior therapy and 29.3% had received ≥2 prior treatment regimens in the metastatic setting. PD-L1 expression ≥1% and ≥5% was reported for 45.9% and 30.7% of patients, respectively. Click here to read the full article at

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