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JULY 9, 2018

FDA Modifies UC Indications of Pembrolizumab, Atezolizumab

The FDA modified the indications of pembrolizumab (Keytruda, Merck) and atezolizumab (Tecentriq, Genentech) to treat urethral cancers, limiting their use to patients with urothelial cancer who are not eligible for platinum-based chemotherapy. 

The change, made official on June 19 and announced on July 2, results from decreased survival associated with the use of these drugs as monotherapy compared with platinum-based chemotherapy in clinical trials, the agency said in a statement.