The approval was based on data from an open label open-label, single-arm study involving 242 patients with locally advanced or metastatic urothelial carcinoma. Avelumab was administered at 10 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity. Prior to each avelumab administration, all patients received an antihistamine and acetaminophen.
The overall response rate was 13.3% (95% CI, 9.1-18.4) among 226 patients who had been followed for at least 13 weeks, and was 16.1% (95% CI, 10.8-22.8) among 161 patients who had been following for at least 6 months. Click here to read the full article at OncLive.com