U.S. Food and Drug Administration (FDA) has approved Opdivo injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response.
required for this drug. Therefore, However, prescribing inform,ation says that no premedicaitons is required. Therefore. Zofran, Decadron, and Diphenhydramine are not clinically appropriate and medically necessary.
Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: January 27, 2017. Princeton, NJ: Bristol-Myers Squibb Company.
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Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017. doi: 10.1016/S1470-2045(17)30065-7.
Gartrell B, Sonpavde G. Emerging Drugs for Urothelial Carcinoma. Expert Opin Emerg Drugs. 2013;18(4):477-94.